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.

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    • Standard
      111 pages
      English and French language

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.

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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 cert...view more

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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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      4 pages
      English language

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 fro...
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      186 pages
      English and French language

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 conditi...
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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 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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    • Standard
      13 pages
      English language
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    • Standard
      13 pages
      English language
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    • Standard
      10 pages
      French language
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    • Standard
      10 pages
      French language

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 S...
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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 ...view more

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    • Standard
      29 pages
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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 ...view more

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    • Standard
      21 pages
      English language
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    • Standard
      23 pages
      French language

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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    • Amendment
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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.

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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 thera...view more

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    • Amendment
      3 pages
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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.

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    • Amendment
      3 pages
      English language
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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 thera...view more

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ISO 10936-2:2010 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ophthalmic surgery.

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    • Standard
      4 pages
      English language
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    • Standard
      4 pages
      English language
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    • Standard
      4 pages
      French language

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 ...view more

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      84 pages
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Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

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      7 pages
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Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

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      7 pages
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2020-01-20: Originator of XML version: NEN (on behalf of NEN, ASI, DS, SFS, SIS, SN)

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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.

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      5 pages
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2020-01-20: Originator of XML version: NEN (on behalf of NEN, ASI, DS, SFS, SIS, SN)

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Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

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    • Standard
      4 pages
      English language
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    • Standard
      4 pages
      French language

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.

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Specification of basic requirements for as well physical characteristics as workmanship, of the steel grades used and heat treatment of component parts, excluding rivets, screws and parts manufactured of material grade M.

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    • Standard
      3 pages
      English language
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    • Standard
      3 pages
      French language
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    • Standard
      3 pages
      French language

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.

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    • Standard
      3 pages
      English language
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    • Standard
      3 pages
      French language
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    • Standard
      3 pages
      French language

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.

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    • Standard
      3 pages
      English language
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    • Standard
      3 pages
      French language
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    • Standard
      3 pages
      French language

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 inten...
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    • Standard
      28 pages
      English language
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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.

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      84 pages
      English language
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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.

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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.

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    • Standard
      7 pages
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This part of ISO 11810 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 this part of ISO 11810 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 this part of ISO 11810 to serve as a ge...view more

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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 ...
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      20 pages
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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...
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    • Standard
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This International Standard specifies 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 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 pe...view more

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    • Standard
      27 pages
      English language
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    • Draft
      27 pages
      English language
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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,...
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      28 pages
      English language
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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, select...
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    • Standard
      27 pages
      English language
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    • Draft
      27 pages
      English language
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      1 day

This International Standard specifies 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 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 pe...view more

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    • Standard
      27 pages
      English language
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      1 day

This International Standard specifies 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 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 pe...view more

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This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice, as defined in 2.1.110 and hereinafter referred to as HF SURGICAL EQUIPMENT. 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 requ...view more

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    • Standard
      89 pages
      English language
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This part of ISO 11810 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 this part of ISO 11810 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 this part of ISO 11810 to serve as a ge...view more

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    • Standard
      19 pages
      English language
    • e-Library read for
      1 day

This International Standard applies 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 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 standard to serve as a general fire sa...
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    • Standard
      19 pages
      English language
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EN following parallel vote

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    • Standard
      44 pages
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