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
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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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
No scope available
- Amendment13 pagesEnglish languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard16 pagesEnglish and French 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.
- Standard111 pagesEnglish and French languagesale 15% off
- Standard230 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
The content of the interpretation sheet 1 (2025-11) has been included in this copy.
- Standard18 pagesEnglish and French languagesale 15% off
IEC 60601-2-41:2021 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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
- Standard93 pagesEnglish languagesale 10% offe-Library read for1 day
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 languagesale 10% offe-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 languagesale 10% offe-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
ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard.
The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items
NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard.
The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items
NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition. All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard. The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.
- Standard21 pagesEnglish languagesale 15% off
- Standard23 pagesFrench languagesale 15% off
- Standard10 pagesEnglish and French languagesale 15% off
ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 10936-2:2010 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ophthalmic surgery.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
IEC 60601-2-2:2009 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technical revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for neutral electrodes.
The contents of the corrigendum of February 2014 have been included in this copy.
- Standard162 pagesEnglish and French languagesale 15% off
This Particular Standard specifies requirements for the safety of high frequency surgical equipment and hf surgical accessories used in medical practice. 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.
- Standard167 pagesEnglish and French languagesale 15% off
Establishes particular requirements for the safety of surgical luminaires and luminaires for diagnosis.
- Standard38 pagesEnglish languagesale 15% off
- Corrigendum4 pagesEnglish languagesale 10% offe-Library read for1 day
2020-01-20: Originator of XML version: NEN (on behalf of NEN, ASI, DS, SFS, SIS, SN)
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.
- Standard5 pagesEnglish languagesale 10% offe-Library read for1 day
Specifies requirements for the safety of high frequency surgical equipment used in medical practice. This third edition of IEC 60601-2-2 cancels and replaces the second edition published in 1991, and constitutes a technical revision.
- Standard41 pagesEnglish languagesale 15% off
2020-01-20: Originator of XML version: NEN (on behalf of NEN, ASI, DS, SFS, SIS, SN)
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Corrigendum4 pagesEnglish languagesale 10% offe-Library read for1 day
Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.
- Standard5 pagesEnglish languagesale 10% offe-Library read for1 day
This standard deals with materials, heat treatment and hardness of component parts, corrosion resistance, workmanship and cutting ability of scissors and shears used in the surgery and defines the test methods.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
- Draft8 pagesEnglish languagesale 15% off
- Draft8 pagesEnglish languagesale 15% off
This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
- Draft4 pagesEnglish languagesale 15% off
- Draft4 pagesEnglish languagesale 15% off
ISO 16061:2015 specifies 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 resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 16061:2008 specifies 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 resupplied after refurbishment.
ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11810-1:2005 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient protective covers which claim to be laser resistant.
The purpose of ISO 11810-1:2005 is to provide a standardized method for testing and classifying surgical drapes and other patient protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of ISO 11810-1:2005 to serve as a general fire safety specification, and as such, this standard does not cover other sources of ignition. It also does not cover the issue of laser-induced secondary ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance may be a hazard. This measurement, however, is not covered in ISO 11810-1:2005.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11810-2:2007 is applicable to disposable and re-usable, as well as woven and non-woven materials used as surgical drapes and/or patient protective covers which claim to be laser-resistant.
The purpose of ISO 11810-2:2007 is to provide a standardized method for testing and classifying surgical drapes and/or patient protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of ISO 11810-2:2007 to serve as a general fire safety specification. ISO 11810-2:2007 is limited to testing the secondary ignition of materials that are rated I1 or I2 from ISO 11810-1.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflection may be a hazard. This measurement, however, is not covered in ISO 11810-2:2007.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This second edition cancels and replaces the first edition (ISO 7153-1:1983): it has been extended to include dental instruments. Contains a survey and a selection of stainless steels available for use in the manufacture of surgical, dental and specific instruments for orthopaedic surgery. It takes into account steel grades and chemical compositions.
- Standard7 pagesEnglish languagesale 10% offe-Library read for1 day