11.040.30 - Surgical instruments and materials
ICS 11.040.30 Details
Surgical instruments and materials
Chirurgische Instrumente und Materialien
Instruments et matériaux chirurgicaux
Operacijski instrumenti in materiali
General Information
Frequently Asked Questions
ICS 11.040.30 is a classification code in the International Classification for Standards (ICS) system. It covers "Surgical instruments and materials". 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 242 standards classified under ICS 11.040.30 (Surgical instruments and materials). 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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- Standard8 pagesEnglish and French languagesale 15% off
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard26 pagesEnglish languagee-Library read for1 day
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard26 pagesEnglish languagee-Library read for1 day
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard18 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
No scope available
- Amendment13 pagesEnglish languagee-Library read for1 day
No scope available
- Amendment13 pagesEnglish languagee-Library read for1 day
This document specifies general requirements and corresponding test methods for a general range of non-cutting instruments in surgery.
- Standard4 pagesEnglish languagesale 15% off
- Amendment11 pagesEnglish languagee-Library read for1 day
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
- Standard111 pagesEnglish and French languagesale 15% off
- Standard230 pagesEnglish and French languagesale 15% off
- Standard16 pagesEnglish and French languagesale 15% off
ABSTRACT
This specification covers the chemical requirements for wrought stainless steels used for the manufacture of surgical instruments. Classes of stainless steels covered here are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification, such as typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, are provided for reference only. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.
SCOPE
1.1 This specification covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments. The data contained in Tables 1-4 of this specification, including typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, is provided for reference only. Mechanical property requirements, heat treating requirements, hardness requirements, and all other requirements except chemistry are governed by the appropriate material standards as referenced below or as agreed upon between the purchaser and supplier.
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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 each other. Combining values from the two systems may result in nonconformance with the standard.
1.3 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 specification8 pagesEnglish languagesale 15% off
- Technical specification8 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers polyetheretherketone (PEEK) polymer in virgin forms as pellets, powder, and so forth. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. The PEEK polymer in the scope of this specification is a pure semicrystalline homopolymer consisting of phenylene rings connected by ether (E) and carbonyl (or ketone, K) groups along the polymer chain. Its polymeric structure is defined by the repeating unit EEK. As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers shall be evaluated using appropriate test methods such as US Pharmacopeia test (infrared spectroscopy, viscosity measurements, and total heavy metal content (as lead)), and differential scanning calorimetry. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. The properties which shall be evaluated are the following: density, tensile strength, elongation, flexural strength, flexural modulus, and impact strength. The biocompatibility of PEEK polymers is also detailed.
SCOPE
1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) and fabricated forms. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.
1.2 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.
1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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.
- Technical specification5 pagesEnglish languagesale 15% off
- Technical specification5 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; bar; or wire. The heat analysis shall conform to the chemical composition prescribed. Material shall be furnished in the beta annealed condition. Bend tests and tension tests shall be performed to conform to the specified requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of each other, and values from the two systems shall not be combined.
1.3 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.
1.4 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 specification6 pagesEnglish languagesale 15% off
- Technical specification6 pagesEnglish languagesale 15% off
The content of the interpretation sheet 1 (2025-11) has been included in this copy.
- Standard18 pagesEnglish and French languagesale 15% off
IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.
HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.
The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
- refinement and additions to the defined terms;
- additional separation of the requirements for HF surgical equipment and HF surgical accessories;
- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;
- new requirements for devices that have or use a high current mode.
- Standard278 pagesEnglish languagesale 15% off
- Standard186 pagesEnglish and French languagesale 15% off
- Standard378 pagesEnglish and French languagesale 15% off
ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumb-type) intended for the retraction, grasping, or dissection of tissue during surgical procedures.
1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.
1.3 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 specification2 pagesEnglish languagesale 15% off
ABSTRACT
This terminology covers the general definitions of terms specific to stainless steel surgical suture needles.
SCOPE
1.1 This terminology covers general definitions for surgical needles.
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.
- Standard3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers general workmanship and test method requirements of stainless steel suture needle holders intended for reuse in surgery. Materials of all component parts shall be fabricated from martensitic stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F, 420F Mod, and 440B. The material shall be heat treated and shall conform to the specified hardness, corrosion resistance, workmanship, finish, and appearance.
SCOPE
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.
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.
- Technical specification2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This test method determines whether Huber needles are designed and manufactured such that they will not produce a core during simulated implantable port access.
5.2 If a needle produces a core during actual use, leaking of the implantable port may occur. Also, the core may be flushed into the port’s reservoir and subsequently into the patient’s body.
SCOPE
1.1 This test method covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access (1).2
1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues.
1.3 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.
1.4 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.
- Standard10 pagesEnglish languagesale 15% off
SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.
1.4 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.
- Standard2 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.
SCOPE
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery.
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.
- Technical specification2 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the general workmanship aspects of inserted and noninserted 410, 410K, 416, 420, 420A, and 420B martensitic stainless steel scissors intended for reuse in surgery. Inserts should be made of stellite, tungsten carbide, or other suitable materials. The instruments should conform to the required values of corrosion resistance cutting ability, Rockwell hardness, and physical properties after passivation and heat treatment. The products should also have finger rings, joints, cutting edges, pivot screws, and finish that are of the required quality.
SCOPE
1.1 This specification covers general workmanship aspects of inserted and noninserted stainless steel scissors fabricated from stainless steel and intended for reuse in surgery.
1.2 The following safety hazards caveat pertains only to the test method described in 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.
1.3 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 specification2 pagesEnglish languagesale 15% off
IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
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.
This particular standard does not apply to
– headlights;
– endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
– luminaires used in dentistry, which are covered by ISO 9680;
– luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
– luminaires dedicated to therapeutic purposes;
– special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment.
IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) revised the statement of essential performance;
b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards;
c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”;
d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify;
e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v;
f) added a requirement for acceptable drift of the lighthead when attached to the suspension system;
g) added a requirement for fluid ingress protection;
h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB;
i) specified a new device for measuring SHADOW DILUTION in a simulated cavity;
j) specified test conditions for luminaires equipped with distance sensors.
- Standard63 pagesEnglish languagee-Library read for1 day
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
- Standard55 pagesEnglish languagee-Library read for1 day
ABSTRACT
This specification establishes the chemical, physical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants. It covers various titanium mill products that are normally formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants. The alloy is usually multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants.
1.2 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 of the two systems may result in nonconformance within the standard.
1.3 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.
1.4 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 specification5 pagesEnglish languagesale 15% off
- Technical specification5 pagesEnglish languagesale 15% off
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
- Standard55 pagesEnglish languagee-Library read for1 day
This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
- Standard23 pagesEnglish languagee-Library read for1 day
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12 molybdenum- 6 zirconium-2 iron alloy for surgical implants to be used in the manufacture of surgical implants. The heat analysis shall conform to the chemical composition requirements prescribed. Ingot analysis may be used for reporting all chemical requirements, except hydrogen. The wrought titanium-12 molybdenum-6 zirconium-2 iron alloy are classified as bar, forging bar and wire. The ultimate tensile strength, yield strength, elongation, and area reduction of the material shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in the manufacture of surgical implants.2
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.
1.3 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 specification5 pagesEnglish languagesale 15% off
- Technical specification5 pagesEnglish languagesale 15% off
ABSTRACT
This specification describes the required properties and the procedures to be followed for testing ultra-high molecular weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. UHMWPE filament and yarn requirements cover compositional requirements, physical requirements, mechanical requirements, and biocompatibility requirements. Residual production liquids shall be determined by gas chromatography or other suitable, validated analytical methods for the specific materials used to produce the yarn.
SCOPE
1.1 This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. This specification covers natural (non-colored) and pigmented (colored) yarns.
1.2 This standard is intended to describe the requirements and the procedures to be followed for testing UHMWPE yarns as a component for medical devices prior to manufacturing processes of the medical device such as fabric formation, assembling, and sterilization. This specification does not purport to address the requirements for the finished medical devices or the testing that is needed for medical devices that are fabricated from the components specified herein.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
1.5 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 specification6 pagesEnglish languagesale 15% off
- Technical specification6 pagesEnglish languagesale 15% off
This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
- Standard23 pagesEnglish languagee-Library read for1 day
NEW!IEC 60601-2-2:2017 is available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode.
- Standard93 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This guide is a guideline for the characterizing and testing of alginate foam scaffolds used in tissue-engineered medical products. Alginate foam scaffolds can be used in a number of tissue engineering and regenerative medicine applications such as anti-adhesion, internal wound healing, and guided tissue regeneration. In addition, alginate foam can be used as a matrix for cell-based cell therapies and for the release of bioactive agents.
SCOPE
1.1 Consistent functionality of scaffolds used in TEMPs can be made more predictable by monitoring relevant characteristics related to physical and biological properties. This guide may be used in the selection of suitable test methods of dried ionically gelled alginate foam scaffolds that may be a component of a medical device or considered a medical device itself.
1.2 This guide provides information relevant for the physical testing of alginate foam scaffolds such as mechanical properties, hydration properties, pore structure, and scaffold degradation. In addition, issues related to biological properties such as elemental impurities, bacterial bioburden, bacterial endotoxins, sterility, and biocompatibility are outlined.
1.3 This guide is intended to be used in conjunction with appropriate characterization and evaluation of any raw or starting materials utilized for fabrication of the alginate foam, such as described in Guides F2027 and F2064.
1.4 This guide addresses alginate foam scaffolds with and without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold.
1.5 Only SI units are used in this 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 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.
- Guide5 pagesEnglish languagesale 15% off
ABSTRACT
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device’s surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.
SCOPE
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.
1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments.
1.3 This practice does not cover producer level handling and packaging procedures.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I—single-slot bit; Type II—cruciate-slot bit; Type III—cross-slot (modified Phillips) bit; Type IV—hexagonal bit; Type V—square bit; Type VI—hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
SCOPE
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants.
1.2 This specification is based, in part, upon ISO 8319-1, ISO 8319-2, and ISO 10664.
1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, and ISO 9268.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
- Technical specification5 pagesEnglish languagesale 15% off
ABSTRACT
This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered. In general, intramedullary reamers consist of two types: one-piece reamer—a design where the reamer shaft and cutting head are permanently attached to each other; and Modular Reamer—a design where the reamer shaft and cutting head are two separate components, fixed to each other temporarily at the time of use via a geometric connection, for example, dovetail joint.
SCOPE
1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone.
1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFDs). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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 specification3 pagesEnglish languagesale 15% off
- Technical specification3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. Physical and mechanical properties of medical grade polyoxymethylene such as specific gravity, water absorption, equilibrium, tensile yield strength, tensile elongation break, tensile modulus, tensile impact strength, compressive strength, and sheer strength shall be determined. Biocompatibility of acetal resins and implant devices made using these materials shall also be determined.
SCOPE
1.1 This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof.
1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for a specific application. Therefore properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy.
1.3 Although this resin has been used for specific implant applications in the United States, the use of this resin in medical devices should be restricted to non-implant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed.
1.4 The biocompatibility of plastic compounds made up of polyoxymethylene (acetal) resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polyacetal should not be assumed on the basis of resin biocompatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. It should be noted that the types, test levels, and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications.
1.5 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this 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 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 and health practices and determine the applicability of regulatory limitations prior to use.
1.8 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 specification3 pagesEnglish languagesale 15% off
SCOPE
1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps).
1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent).
1.3 This specification represents the best currently available test procedures and is a minimum safety and performance standard.
1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories.
1.5 This specification describes those devices commonly known as skull clamps and accessories, such as skull pins, attachments, and various adaptors.
1.6 This specification only describes head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the outer surface or outer layers of the patient’s head during neurosurgical or spinal procedures (compare with Ref (1)).2 Two pins are typically located in a 2-pin rocker, whereas the force delivery component is equipped with a single pin.
1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. The values given in parentheses are for information only.
1.8 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.
FIG. 1 Skull Clamp Device Achieving 3-Pin Rigid Fixation
FIG. 2 Skull Clamp System (Skull Clamp, Base Unit, Adaptor, and Skull Pins)
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 specification9 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures.
FIG. 1 Components of a Scissors (Inserted and Non-Inserted)
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.
- Standard2 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the dimensions and tolerances for both driving and driven elements in square drive interconnections on stainless steel surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery. The specification is intended to lessen the chance of accidental disengagement of surgical instruments.
SCOPE
1.1 This specification applies to interconnections of surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery.
1.2 This specification includes dimensions and tolerances for both driving and driven elements.
1.3 The specifications given in ASME B107.4M-1995 are designed for industrial applications and are considered too loose for surgical applications. Springs used for industrial applications are generally made from carbon steel and are capable of higher loads than their stainless steel counterparts. The specifications given in this standard have been written to lessen the chance of accidental disengagement of surgical instruments. This accidental disengagement could injure the patient or end user, or damage or contaminate the instrument.
1.4 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 non-conformance with the standard.
1.5 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 specification5 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology covers basic terms and considerations for the components of hemostatic forceps. Instruments in this terminology are limited to those fabricated from stainless steel and for general surgical procedures. See Fig. 1 and Fig. 2.
FIG. 1 Components of a Hemostatic Forceps
FIG. 2 Typical Types of Serrations and Teeth for Hemostatic Forceps
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.
- Standard3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.
SCOPE
1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants.
1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components. Finished NiTi cold-worked tube should be considered under Specification F2633.
1.3 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 non-conformance with the standard.
1.4 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 specification6 pagesEnglish languagesale 15% off
- Technical specification6 pagesEnglish languagesale 15% off
- Standard93 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 Consideration of the flexural stiffness of medical textiles is important, as these devices often need to possess properties that allow them to conform readily to the anatomic structures they are designed to support or protect. This test method outlines the materials and methods for the determination of flexural properties along the different textile directions (that is, machine and cross-machine) and for the effects of textile surface orientation (that is, face and back orientations).
5.2 This test method can be used for quality control purposes.
5.3 This test method can be used for non-absorbable, absorbable, and partially absorbable medical textiles including films and membranes. Testing should be performed on both dry and appropriately conditioned specimens. If the specimen is fabricated from a hydrolytically degradable absorbable material or contains an absorbable component, testing after hydrolytic conditioning at appropriate time intervals should be undertaken using Test Method F1635. For partially absorbable textiles, testing should be performed through at least two time intervals that exceed the point where the absorbable component no longer contributes to the specimen’s measurable mechanical properties.
5.4 If flexural rigidity values are found to show effects related to planar and surface orientation, results from this test method could potentially help in determining if devices should be implanted or used only at specific textile directions and surface orientations. Considerations for determining device planar and surface orientations for use would include, but are not limited to, primary direction of bending once implanted or during use, anatomic structures that will interact with the device, and physiologic loads (normal, pathological, and worst-case) the device would experience during use.
5.5 No evidence has been found showing that bending length is dependent on the width. However, the tendency for specimens to curl or twist can affect...
SCOPE
1.1 This test method covers the measurement of flexural stiffness properties of medical textiles (for example, surgical mesh, films, and membranes). Bending length is measured and flexural rigidity is calculated.
1.2 This test method may be used for absorbable or non-absorbable medical textiles.
1.3 This test method measures the flexural stiffness at room temperature in air and, if used directly, may not provide an accurate measure of in-vivo behavior for implantable medical textiles.
1.4 This test method is not suitable for testing tubular samples.
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.
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 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.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
3.1 This test method provides corrosion test methodologies and means of evaluation that serve as indicators of proper material selection and proper processing by the manufacturer.
Note 1: It is recommended that instruments be chemically passivated according to one of the treatments in Specification A967, electropolished according to Specification B912, or both, prior to evaluating the corrosion resistance according to this test method. The likelihood of failure may be higher for non-passivated instruments.
SCOPE
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899.
1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium.
1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.
1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials.
1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5).
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or other anodic surface contaminants on stainless steel.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 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.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.
SIGNIFICANCE AND USE
A1.3 Significance and Use
A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.
A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.
A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.
SCOPE
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples—Annex A1.
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2.
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex A4.
1.3 The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only.
1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.
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.
- Technical specification13 pagesEnglish languagesale 15% off
- Technical specification13 pagesEnglish languagesale 15% off
ISO 10936-1:2017 specifies requirements and refers to test methods for operation microscopes used for observation during surgical operation and treatment of patients. It does not apply to accessories, e.g. photographic cameras. NOTE Specific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery are given in ISO 10936‑2.
- Standard4 pagesEnglish languagesale 15% off
ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
- Standard20 pagesEnglish languagee-Library read for1 day
ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
- Standard20 pagesEnglish languagee-Library read for1 day
ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry. While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
- Standard13 pagesEnglish languagesale 15% off
- Standard13 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
- Standard10 pagesFrench languagesale 15% off