11.140 - Hospital equipment
ICS 11.140 Details
Hospital equipment
Krankenhausausstattung
Équipements des hôpitaux
Oprema bolnišnic
General Information
Frequently Asked Questions
ICS 11.140 is a classification code in the International Classification for Standards (ICS) system. It covers "Hospital equipment". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 280 standards classified under ICS 11.140 (Hospital equipment). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm. If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply. This document does not apply to: • ADULT only beds covered by IEC 80601-2-52; • SPECIALITY MATTRESS covered by the ISO 20342 series; • incubators covered by IEC 60601-2-19; • devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table). If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
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- Draft100 pagesEnglish languagesale 15% off
IEC 80601-2-89:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm.
If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply.
This document does not apply to:
• ADULT only beds covered by IEC 80601-2-52;
• SPECIALITY MATTRESS covered by the ISO 20342 series;
• incubators covered by IEC 60601-2-19;
• devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table).
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
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This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.
- Standard23 pagesEnglish languagee-Library read for1 day
This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.
- Standard23 pagesEnglish languagee-Library read for1 day
This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This document is not applicable to face masks intended exclusively for the personal protection of staff. Compliance with this standard does not demonstrate compliance with the requirements of the relevant PPE regulations.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223-1) concerning manufacturing and processing requirements.
This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.
This document does not include information on resistance to penetration by laser radiation of products.
NOTE If resistance to penetration by laser radiation is claimed for surgical drapes, suitable test methods together with an appropriate classification system are given in EN ISO 11810.
This document does not cover requirements for incision drapes or films.
This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.
- Standard33 pagesEnglish languagee-Library read for1 day
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223-1), concerning manufacturing and processing requirements.
This document gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
This document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
- Standard30 pagesEnglish languagee-Library read for1 day
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223-1) concerning manufacturing and processing requirements.
This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.
This document does not include information on resistance to penetration by laser radiation of products.
NOTE If resistance to penetration by laser radiation is claimed for surgical drapes, suitable test methods together with an appropriate classification system are given in EN ISO 11810.
This document does not cover requirements for incision drapes or films.
This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.
- Standard33 pagesEnglish languagee-Library read for1 day
This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This document is not applicable to face masks intended exclusively for the personal protection of staff. Compliance with this standard does not demonstrate compliance with the requirements of the relevant PPE regulations.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223-1), concerning manufacturing and processing requirements.
This document gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
This document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
- Standard30 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
- Standard10 pagesEnglish languagee-Library read for1 day
IEC 60601-2-46:2023 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This particular standard does not apply to
- dental patient chairs (see ISO 7494-1),
- examination chairs and couches,
- patient-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43),
- operating table heating blankets (see IEC 60601-2-35),
- patient transfer equipment,
- delivery tables and delivery beds,
- medical beds (see IEC 60601-2-52 and EN 50637), and
- field tables.
IEC 60601-2-46:2023 cancels and replaces the third edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
- Standard32 pagesEnglish languagee-Library read for1 day
IEC 60601-2-46:2023 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This particular standard does not apply to - dental patient chairs (see ISO 7494-1), - examination chairs and couches, - patient-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43), - operating table heating blankets (see IEC 60601-2-35), - patient transfer equipment, - delivery tables and delivery beds, - medical beds (see IEC 60601-2-52 and EN 50637), and - field tables. IEC 60601-2-46:2023 cancels and replaces the third edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
- Standard10 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
- Standard14 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
- Standard14 pagesEnglish languagee-Library read for1 day
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
- Standard43 pagesEnglish languagee-Library read for1 day
- Amendment10 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.
5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.
5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usual continuous regions of protective clothing items.
5.2 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 42 to 60 dyn/cm (0.042 to 0.060 N/m) (1).7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is approximately 40 ± 5 dyn/cm (0.040 ± 0.005 N/m).
5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood.
5.4 Part of the protocol in Procedures A and B in Table 1 for exposing the protective clothing material specimens with synthetic blood involves pressurizing the test cell to 13.8 kPa [2.0 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and to correlate with visual penetration results that are obtained with a human factors validati...
SCOPE
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick inner liners which readily absorb the synthetic blood.
1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671/F1671M.
1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognize...
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- Standard7 pagesEnglish languagesale 15% off
- Amendment10 pagesEnglish languagee-Library read for1 day
- Standard13 pagesEnglish and French languagesale 15% off
IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.
IEC 60601-2-35:2020 does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- cooling devices.
IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
- Standard70 pagesEnglish languagesale 15% off
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SCOPE
1.1 This specification establishes specifications and test requirements for protectors to be worn over electrical workers’ rubber insulating gloves.
1.2 It is intended that the protectors specified herein fit snugly over rubber insulating gloves specified in Specification D120 without causing mechanical damage to the rubber insulating glove. Cinching at the wrist is allowed.
1.3 This specification covers the use of a material or combination of materials which do not compromise the integrity of the rubber insulating glove.
1.4 Specification F696 was used to establish minimums for this specification.
1.5 Protectors meeting this specification do not provide any electrical shock protection if used on their own.
1.6 This specification specifies the response of protectors to electric arc, puncture and cut under controlled conditions.
1.6.1 Field conditions will not directly correlate to testing methods.
1.7 The values stated in SI units are to be regarded as the standard except as noted. See IEEE/ASTM SI-10.
1.8 The following safety hazards caveat pertains only to the test method portion, Sections 6 and 7, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification4 pagesEnglish languagesale 15% off
- Technical specification4 pagesEnglish languagesale 15% off
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
- Standard43 pagesEnglish languagee-Library read for1 day
ABSTRACT
This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
SIGNIFICANCE AND USE
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Performance requirements are established for important physical properties, including tensile strength, tear strength, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, and abrasion resistance are provided.
4.2 This specification does not address protective clothing used for nonsurgical applications, such as isolation gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.
4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization.
4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65.
4.5 While surgical gowns are classified for barrier performance...
SCOPE
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes.
Note 1: Some properties require minimum performance and others are for documentation only.
Note 2: ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.
1.3 This specification is not intended to serve as a detailed manufacturing or purchase...
- Technical specification11 pagesEnglish languagesale 15% off
- Technical specification11 pagesEnglish languagesale 15% off
IEC 60601-2-46:2023 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This particular standard does not apply to
- dental patient chairs (see ISO 7494-1),
- examination chairs and couches,
- patient-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43),
- operating table heating blankets (see IEC 60601-2-35),
- patient transfer equipment,
- delivery tables and delivery beds,
- medical beds (see IEC 60601-2-52 and EN 50637), and
- field tables.
IEC 60601-2-46:2023 cancels and replaces the third edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
- Standard85 pagesEnglish languagesale 15% off
- Standard54 pagesEnglish and French languagesale 15% off
ABSTRACT
This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.
SCOPE
1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care.
1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks).
1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.
1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to their overall barrier and breathability properties.
1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face.
1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards.
Note 1: Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted.
5.2 This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections.
5.3 This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor.
5.4 Unless otherwise specified, the testing shall be performed with the inside of the medical face mask in contact with the bacterial challenge. Testing may be performed with the aerosol challenge directed through either the face side or liner side of the test specimen, thereby allowing evaluation of filtration efficiencies which relate to both patient-generated aerosols and wearer-generated aerosols.
5.5 Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, an...
SCOPE
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.
1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %.
1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.
1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material do not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.
1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the standard.
1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.
1.7 This test method may also be used to measure the bacterial filtration efficienc...
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesEnglish languagesale 15% off
This document specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. This document is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. This document covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. This document is intended to be a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this document.
- Standard11 pagesEnglish languagesale 15% off
IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.
- Standard27 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 This practice establishes the national standard for training the EMT in communicating pertinent patient information to the receiving medical facility.
4.2 Appropriate physiological data and patient assessment information should be collected from the scene or while en route to the receiving medical facility or medical command site.
4.3 This practice is based on the information needs of a receiving medical facility to assist them in medical triage, ED resource management, and the provision of medical direction.
4.4 This practice should be used by those who develop curricula, provide continuing medical education, or desire a needs-based reporting approach.
4.5 This practice should be used to develop documentation aids such as EMS notepads and medical command documentation sheets.
4.6 The communication format in each PISA subsection in this practice are not necessarily in sequential order. The report may vary dependent upon patient presentation.
SCOPE
1.1 This practice establishes the EMS standard for communications entailing a patient radio (phone) report to a receiving medical facility.
1.1.1 This report is based on receiving facility needs and is generic for medical, traumatic (ALS), and (BLS) patients.
1.1.2 This report standard is based on the hierarchical information needs of an average medical receiving facility.
1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.
5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.
5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions, as well as the usual continuous regions of protective clothing items.
5.2 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants; however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms (1-3).7 This test method uses media containing Phi-X174 Bacteriophage. The visual detection technique of this test method is supplemented with a biologically based assay capable of detecting virus under the specified test conditions.
5.3 Test Method F1670/F1670M allows the screening of protective clothing materials for resistance to penetration with synthetic blood as a challenge liquid. Test Method F1670/F1670M uses the same penetration test cell and technique, but exposes material specimens to synthetic blood with visual detection of liquid penetration. Materials passing Test Method F1670/F1670M should then be tested against bacteriophage penetration using this test method to verify performance.
5.4 This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate for HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basi...
SCOPE
1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the liquid assay fluid.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications.
1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other pathogens must be assessed on a case-by-case basis.
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing and determined to be viral resistant. This test method does not address the design, overall construction and components, or interfaces of garments or other factors which may affect the overall protection offered by the protective clothing.
1.5 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This i...
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- Standard11 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide is intended for use by those undertaking the development of fire hazard assessments for upholstered seating furniture in health care occupancies.
4.2 As a guide this document provides information on an approach to development of a fire hazard assessment, but fixed procedures are not established. Section 1.7 describes some cautions to be taken into account.
4.3 A fire hazard assessment developed following this guide should specify all steps required to determine fire hazard measures for which safety thresholds or pass/fail criteria can be meaningfully set by responsible officials using the standard.
4.4 A fire hazard assessment developed as a result of using this guide should be able to assess a new item of upholstered seating furniture being considered for use in a certain health care facility, and reach one of the conclusions in 4.4.1 – 4.4.4.
4.4.1 The new upholstered seating furniture item is safer, in terms of predicted fire performance, than the one in established use. Then, the new product would be desirable, from the point of view of fire safety.
4.4.2 There is no difference between the predicted fire safety of the new item and the one in established use. Then, there would be neither advantage nor disadvantage in using the new product, from the point of view of fire safety.
4.4.3 The new upholstered seating furniture item is predicted to be less safe, in terms of fire performance, than the one in established use. Then, the new item would be less desirable, from the point of view of fire safety than the one in established use.
4.4.3.1 If the new upholstered furniture item is predicted to be less safe, in terms of fire performance, than the one in established use, a direct substitution of the products would provide a lower level of safety and the new product should not be used, without other compensatory changes being made. A new upholstered furniture product can, however, be made acceptable if, and only if, it is part of a co...
SCOPE
1.1 This is a guide to developing fire hazard assessments for upholstered seating furniture, within patient rooms of health care occupancies. As such, it provides methods and contemporary fire safety engineering techniques to develop a fire hazard assessment for use in specifications for upholstered seating furniture in such occupancies.
1.2 Hazard assessment is an estimation of the potential severity of the fires that can develop with certain products in defined scenarios, once the incidents have occurred. Hazard assessment does not address the likelihood of a fire occurring, but is based on the premise that an ignition has occurred.
1.3 Because it is a guide, this document cannot be used for regulation, nor does it give definitive instructions on how to conduct a fire hazard assessment.
1.4 This guide is intended to provide assistance to those interested in mitigating the potential damage from fires associated with upholstered furniture in patient rooms in health care occupancies.
1.5 Thus, this guide can be used to help assess the fire hazard of materials, assemblies, or systems intended for use in upholstered furniture, by providing a standard basis for studying the level of fire safety associated with certain design choices. It can also aid those interested in designing features appropriate to health care occupancies. Finally, it may be useful to safety personnel in health care occupancies.
1.6 This guide is a focused application of Guide E1546, which offers help in reference to fire scenarios that are specific to upholstered furniture in health care occupancies, and includes an extensive bibliography. It differs from Guide E1546 in that it offers guidance that is specific to the issue of upholstered furniture in patient rooms of health care facilities, rather than general guidance. Appendix X11 includes some statistics on the magnitude of the potential problem in the U.S.
1.7 A fire hazard assessm...
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- Guide23 pagesEnglish languagesale 15% off
This document recommends characteristics, test methods and minimum performance specifications for unused textile for the healthcare and social service facilities (hospitals, residential care homes, etc.) to give guidance on the suitability of products intended to be maintained by industrial laundering.
This document is not applicable to surgical textiles under the Medical Devices Directive nor protective clothing under the PPE Directive.
- Technical specification22 pagesEnglish languagee-Library read for1 day
This document recommends characteristics, test methods and minimum performance specifications for unused textile for the healthcare and social service facilities (hospitals, residential care homes, etc.) to give guidance on the suitability of products intended to be maintained by industrial laundering.
This document is not applicable to surgical textiles under the Medical Devices Directive nor protective clothing under the PPE Directive.
- Technical specification22 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 The United States has concentrated attention and testing efforts on surgical scrubbing far more than on hand care in patient-to-patient routines. Great Britain, the originators of infection control nursing, have always had their focus on infection transmission. In the United States, published articles have documented the short exposure time for health care personnel who do wash their hands between patients. The average is less than 10 s. The ideal product for the reduction of transient flora is one that rapidly kills or removes or both the microbial load acquired during health care activities. The emphasis on rapidity is essential simply because health care personnel will not take the necessary time when using conventional hand-washing products. The use of products not intended for use with water has increased dramatically and their use is common in European countries largely because of convenience and effectiveness. A second characteristic is the level of antimicrobial action. The use of a rapid and potent active product to reduce work-acquired microbial flora is ideal.
4.2 Since the change from strictly in-vitro testing of topical antimicrobials for use on skin to simulated use testing in hand washing, prepping, site access testing, and sampling, emphasis has always been on washing hands, agitating, rubbing, and brushing with liquid on the skin site to estimate bacteria removed after testing.
4.3 The use of hard agitation has diminished with surgical scrubs without brushes or with only mild agitation and friction.
4.4 There is a history of microbial dispersal (9) and increase in surface bacteria from deeper layers resulting from showering (10-12), washing, scrubbing, and agitation. In the normal situation on the skin, there is a superficial, surface flora and a deeper or hidden flora (5). The proportion of one to the other has been addressed by Selwyn (4) and his judgment is that from 20 to 50 % of the flora is “deep.” The intent in skin sampling has...
SCOPE
1.1 This guide covers test methods and sampling procedure options for leave-on products for consumer and hospital personnel. Leave-on products, such as alcohol hand rubs and lotions containing antimicrobial ingredients, are increasingly marketed and used by consumers and health care personnel. These products are distinguished from conventional washing and scrubbing preparations in that they do not rely on the rinsing, physical removal, and antimicrobial action in determining their effectiveness. Although agitation and friction may serve to release organisms from the skin and folds and crevices, organisms are then killed in situ and are not rinsed from the skin surface before sampling. Appropriate test methods for the hands have been published, while other sampling methods will be needed for testing body areas other than the hands.
1.1.1 Researchers have described techniques to identify the expanded flora we now know can be present on the skin. It is impractical, if not prohibitive to attempt to recover and identify these varieties of organisms with each test. At some point in the design of a test, a decision is necessary for defining the target organisms. Should the sampling be designed to recover as much of the microflora as possible or a particular portion of it? Consideration of transient and resident, superficial and deep, or aerobic and anaerobic flora must be included in defining the objective in testing products. The recovery methods selected for any testing must be based on the projected use of the product type being tested.
1.2 Methods of recovery after application of the contaminating organisms to a part of the body other than by the agitation/rubbing of the hands against a glass petri plate also need examination. Consideration should be given to contact plating, controlled swabbing with a template, and cup scrubbing (detergent/agitation used) since the target organisms for recovery are likely to be on th...
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IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.
IEC 60601-2-35:2020 does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- cooling devices.
IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
- Standard73 pagesEnglish languagee-Library read for1 day
- Standard73 pagesEnglish languagee-Library read for1 day
IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-35:2020 does not apply to: - HEATING DEVICES intended for physiotherapy; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - cooling devices. IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
- Standard73 pagesEnglish languagee-Library read for1 day
- Standard73 pagesEnglish languagee-Library read for1 day
201.1 Scope, object and related standards Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows: 201.1.1 * Scope Replacement: This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions. This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm. NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT. If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard. This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52). This Standard does not apply to : - incubators covered by EN 60601-2-19 ; - beds for children, covered by EN 716-1 and EN 716-2 ; - cribs and cradles covered by EN 1130 (all parts) ; - bunk beds and high beds, covered by EN 747-1 and 747-2. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006. NOTE 2 See also 4.2 of EN 60601-1:2006. NOTE 3 Body length is measured from crown to sole.
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This document specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. This document is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.
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IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.
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SIGNIFICANCE AND USE
5.1 This test method was modeled after a procedure commonly known as the Elbow Lean Test.8 The Elbow Lean Test involves the application of synthetic blood to an ink pad, placement of sample fabric over the blood-soaked pad, placement of a blotter over the sample fabric, and applying elbow or fingertip pressure on top of the blotter. The blotter is then examined for staining as evidence of blood penetration. This test method provides similar procedures which standardize the test equipment and application of pressure through an adopted methodology.
5.2 This test method is intended to simulate actual use conditions wherein areas of the healthcare worker's protective clothing are soaked with blood and compressed between the patient's body and that of the healthcare worker, or similarly between the healthcare worker and instruments. In both cases, unconfined blood can move away from the pressure point taking the path of least resistance rather than being contained as in Test Methods F1670/F1670M and F1671/F1671M.
5.3 This test method uses predominately mechanical pressure as opposed to contained, hydrostatic pressure to demonstrate liquid penetration resistance (1, 2) . It simulates a single insult in which the outer surfaces of a protective clothing item are compressed at a steady rate by the wearer's body against a wet surface. This steady rate of compression represents one potential use scenario. Other scenarios may result in a wide variety of pressure ramp rates and profiles that are not simulated by the test apparatus.
5.4 Because this test method provides quantitative results, it is useful for discriminating differences in the liquid barrier performance of protective clothing materials. This test method can be used for measuring differences in the penetration pressure for protective clothing materials which do not pass Test Method F1670/F1670M.
5.5 This test method is normally used to evaluate specimens from individual finished items of protective cloth...
SCOPE
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based on visual detection of synthetic blood penetration at a specific applied mechanical pressure.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.
1.4 The values in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesEnglish languagesale 15% off
This document specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.
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- Standard26 pagesFrench languagesale 15% off
This Technical Specification sets out the framework and structure for the standard related to ventilation in hospitals. It gives the requirements for the drafting of the parts of the standard, including preliminary terms and definitions.
The standard for ventilation in hospitals is intended for all healthcare premises where healthcare services are delivered. It is applicable for healthcare services located in a hospital, clinic or other premises. This includes general and specific risk areas, within healthcare and provides defined levels of air quality/cleanliness for classification of these areas. The standard addresses the minimum requirements for ventilation systems. It specifies the design, installation, operation, qualification process and maintenance of the ventilation systems.
The standard describes the following hygienic issues related to the ventilation system:
a) air quality (e.g. cleanliness levels, temperature, humidity, air quantity);
b) the protection of patients, staff and visitors against harmful agents;
c) reducing the growth of microorganisms (e.g. clean-ability, accessibility, wet surfaces, accumulation of particles);
d) control of the airflow direction (e.g. tightness of systems and constructions, pressure difference).
The standard describes a structured approaches for all phases from design up to and including maintenance and requalification and gives minimum requirements for the ventilation systems:
a) minimum user requirement specification (URS);
b) functional design requirements (FD);
c) requirements for components in the detailed design (DD).
This standard is intended for healthcare ventilation system project managers, designers, construction and commissioning engineers, estates managers and operations/facilities managers.
- Technical specification28 pagesEnglish languagee-Library read for1 day
IEC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.
- Amendment10 pagesEnglish languagee-Library read for1 day
This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination.
NOTE Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5.
This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.
- Technical report23 pagesEnglish languagee-Library read for1 day
201.1 Scope, object and related standards
Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows:
201.1.1 * Scope
Replacement:
This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.
This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.
NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.
If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.
This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52).
This Standard does not apply to :
- incubators covered by EN 60601-2-19 ;
- beds for children, covered by EN 716-1 and EN 716-2 ;
- cribs and cradles covered by EN 1130 (all parts) ;
- bunk beds and high beds, covered by EN 747-1 and 747-2.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006.
NOTE 2 See also 4.2 of EN 60601-1:2006.
NOTE 3 Body length is measured from crown to sole.
- Standard89 pagesEnglish languagee-Library read for1 day
This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination.
NOTE Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5.
This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.
- Technical report23 pagesEnglish languagee-Library read for1 day
IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA). This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on: - methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA; - considerations of basic safety and essential performance for an MEE and MES with a DOA; and - identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and - distinguishing between medical robots, and other MEE and MES. Unless specified otherwise, this document considers MEE and MES together. The manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle. This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers. There are no prerequisites to this document.
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- Technical report80 pagesEnglish languagesale 15% off
IEC TR 62343-6-10:2017(E) which is a Technical Report, discusses the rationale, conceptual definition, and minimum list of functions for an intermediate controller that delivers a dynamic control signal to multiple dynamic modules. These modules are included in an optical-switch-based network node, according to the upper layer controller of software-defined optical networking.
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