IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies bot...
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    • Standard
      70 pages
      English language

This document specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. This document is intended as a reference for the performance and safety of rubber ...view more

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    • Standard
      10 pages
      English language
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    • Draft
      9 pages
      English language

This document specifies requirements and provides the test method for medical gloves for single use in order to determine freedom from holes.

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    • Standard
      8 pages
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IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.

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    • Standard
      27 pages
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IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.

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      27 pages
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This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European St...
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This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European St...
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This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clin...view more

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      33 pages
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This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and...view more

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      29 pages
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This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and...view more

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    • Standard
      29 pages
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This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clin...view more

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      33 pages
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This Technical Specification sets out the structure for a standard related to ventilation in hospitals. It gives the requirements for the drafting of the parts of the standard, including common terms and definitions.
The standard for ventilation in hospitals is intended for all healthcare premises where healthcare services are delivered. It is applicable for healthcare services located in a hospital, clinic or other premises. It includes general and specific risk areas, and provides defined lev...
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    • Technical specification
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This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination.
NOTE   Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523 1,...
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This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.
This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body l...
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201.1 Scope, object and related standards Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows: 201.1.1 * Scope Replacement: This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition f...view more

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    • Standard
      89 pages
      English language
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This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination.
NOTE   Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1,...
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IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA). This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on: - methodologies to perform the risk management process and usability ...view more

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      80 pages
      English language

IEC TR 62343-6-10:2017(E) which is a Technical Report, discusses the rationale, conceptual definition, and minimum list of functions for an intermediate controller that delivers a dynamic control signal to multiple dynamic modules. These modules are included in an optical-switch-based network node, according to the upper layer controller of software-defined optical networking.

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      15 pages
      English language

ISO 22882:2016 specifies the technical requirements, the appropriate dimensions and the requirements for the testing of swivel castors for hospital beds with a wheel diameter of 100 mm or more and which have a central locking device. Swivel castors may be used with the main principal dimensions.

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    • Standard
      11 pages
      English language

IEC 60601-2-46:2016 is available as IEC 60601-2-46:2016 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-46:2016 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This thir...
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      50 pages
      English and French language

IEC TS 62840-1:2016(E) gives the general overview for battery swap systems, for the purposes of swapping batteries of electric road vehicles (EVs) when the vehicle powertrain is turned off and when the battery swap system is connected to the supply network at standard supply voltages according to IEC 60038 with a rated voltage up to 1 000 V AC and up to 1 500 V DC. It is applicable for battery swap systems for EV equipped with one or more swappable battery system (SBS).

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    • Technical specification
      27 pages
      English language

This Technical Specification recommends characteristics, test methods and minimum performance
specifications for unused textile for the healthcare and social service facilities (hospitals, residential
care homes, etc.) to give guidance on the suitability of products intended to be maintained by industrial
laundering.
This Technical Specification is not applicable to surgical textiles under the Medical Devices Directive
nor protective clothing under the PPE Directive.

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    • Technical specification
      19 pages
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This Technical Specification recommends characteristics, test methods and minimum performance specifications for unused textile for the healthcare and social service facilities (hospitals, residential care homes, etc.) to give guidance on the suitability of products intended to be maintained by industrial laundering.
This Technical Specification is not applicable to surgical textiles under the medical devices directive nor protective clothing under the PPE directive.

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      19 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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D142/047: NWI approved for UAP * Document prepared by a Joint Working Group IEC/SC 62D & ISO/TC 173

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    • Amendment
      10 pages
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This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommende...
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IEC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

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    • Amendment
      10 pages
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This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

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    • Standard
      34 pages
      English language
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This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The r...
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      11 pages
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The proposed standard specifies the performance requirements applying to cabinets designed to store and dry heat-sensitive endoscopes (SCHE) following automated or manual reprocessing. The storage cabinets are designed to provide a controlled environment for storage of endoscope(s) and when necessary drying of the endoscope(s), including the endoscope(s) channels. The controlled environment is provided to ensure that during storage there is no deterioration of the microbial quality of the endosc...view more

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      59 pages
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This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

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      34 pages
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This European Standard specifies the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing.
The storage cabinets are designed to provide a controlled environment for storage of endoscope(s), with or without channels, and when necessary drying of the endoscope(s), including the endoscope(s) channels.
The controlled environment provided by the storage cabinet ensures that during storage there is no dete...
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IEC 62894:2014 describes data sheet and name plate information for photovoltaic inverters in grid parallel operation. The object of this standard is to provide minimum information required to configure a safe and optimal system with photovoltaic inverters.

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    • Standard
      25 pages
      English and French language

ISO 10282:2014 specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. ISO 10282:2014 is intended as a reference for the performance and safety of rubber surgical ...view more

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    • Standard
      11 pages
      English language

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this International Standard. 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 ...view more

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    • Amendment
      3 pages
      English language
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EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

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    • Corrigendum
      2 pages
      English language
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This particular standard specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top.

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    • Standard
      24 pages
      English language
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      1 day

IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.

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    • Standard
      24 pages
      English language
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      1 day

EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

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    • Corrigendum
      2 pages
      English language
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in 201.3.212. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended p...view more

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    • Standard
      87 pages
      English language
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EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

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    • Standard
      87 pages
      English language
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      1 day

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this International Standard. 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 ...view more

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    • Standard
      72 pages
      English language
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IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition...view more

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    • Standard
      72 pages
      English language
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IEC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. The contents of the corrigendum of September 2010 have been ...view more

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    • Standard
      168 pages
      English and French language