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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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
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
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IEC 60601-2-2:2017 is also 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.
- Standard278 pagesEnglish languagesale 15% off
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This part of IEC 60601 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.
NOTE See also 4.2 of the general standard.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general
lighting equipment.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL
SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their
INTERACTION CONDITIONS and INTERFACE CONDITIONS. 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 RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the
particular standard applies in addition to this standard.
EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT;
IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for
operating tables, etc
- 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 nonactive
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
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
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.
- 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.
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- 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
This part of ISO 7153 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 this part of ISO 7153 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.
NOTE When selecting the grade of steel and the shape, dimensions and delivery conditions of the raw
material for manufacturing surgical instruments, it is necessary to take into account factors, such as the design
of the instrument or the production facilities of the manufacturer, that are not covered by this part of ISO 7153.
For this reason, it is not intended, nor is it possible, for the information given in this part of ISO 7153 to remove
the decision-making responsibility from the instrument manufacturer for selecting an appropriate raw product
with suitable properties; nor is it intended to preclude the use of other types of steel in the manufacture of
instruments, such as the use of carbon steel for cutting instruments. International Standards for surgical
instruments, when published, can be observed when making this decision as they may contain additional or new
information to be taken into account when selecting appropriate steel grades.
- 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.
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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
This International Standard 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-laserresistant
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.
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- Standard23 pagesFrench languagesale 15% off
2020-11-04-JO - lack of compliance. Refereince is made CLC/TC 62 Decision 02/2019 in Oslo 2019 to decouple work items from MDD and AIMD for projects that do not yet have an Annex ZZ approved by the HAS consultant.. Following exchange with TC leadership and given that the transition of MDD ends in May 2021, the TC will rather focus on the citation of their standards under the MDR. The link to MDD and M/295 removed to the published standard
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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
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. 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 UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; - lights connected to surgical instruments; - luminaires of an emergency lighting, which are covered by IEC 60598-2-22.
- Amendment3 pagesEnglish languagesale 10% offe-Library read for1 day
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. 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 UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; - lights connected to surgical instruments; - luminaires of an emergency lighting, which are covered by IEC 60598-2-22.
- Standard44 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
Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Standard7 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.
- Standard7 pagesEnglish languagesale 10% offe-Library read for1 day
Establishes particular requirements for the safety of surgical luminaires and luminaires for diagnosis.
- Standard38 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
This International Standard lays down the dimensions of two sizes of fitting features for detachable scalpel blades and the handles with which they are used.
- 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
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- 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
Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
- Draft20 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.
- Draft20 pagesEnglish languagesale 10% offe-Library read for1 day
No scope available
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No scope available
- Draft11 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT as defined in 201.3.222. 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.
- Amendment3 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 16061:2015 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
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
SURGICAL EQUIPMENT as defined in 201.3.222. 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.
- Standard84 pagesEnglish languagesale 10% offe-Library read for1 day