11.040.01 - Medical equipment in general
Medical equipment in general
Medizinische Gerate im allgemeinen
Matériel médical en général
Medicinska oprema na splošno
General Information
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser
equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications,
intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the
ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4.
MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as
sources of energy being transferred to the PATIENT or animal and where the las...view more
- Standard33 pagesEnglish language
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2020-10-13_JO_CLC/TC 62 Decision 2019-05-21/22 in Oslo to remove the link to the published standard
- Amendment7 pagesEnglish language
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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...view more
- Standard70 pagesEnglish language
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2020-10-13:JO-CLC/TC 62 Decision 2019-05-21/22 in Oslo to remove the link to the published standard
- Amendment9 pagesEnglish language
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This document addresses good clinical practice for the design, conduct, recording and reporting of
clinical investigations carried out in human subjects to assess the clinical performance or effectiveness
and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be
followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
— ...view more
- Standard96 pagesEnglish language
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- Draft96 pagesEnglish language
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The proposed Technical Report is to provide a common understanding of post-market surveillance, or
PMS facilitating international cooperation in this area. The Technical Report is intended for use by
manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices.
The proposed Technical Report aims to describe a ...view more
- Technical report52 pagesEnglish language
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- Technical report49 pagesEnglish language
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2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076
- Amendment22 pagesEnglish language
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- Standard51 pagesEnglish language
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This document provides guidance on the development, implementation and maintenance of a risk
management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based
on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016
(Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are
related to risk management and can b...view more
- Technical report96 pagesEnglish language
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- Technical report92 pagesEnglish language
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- Standard58 pagesEnglish language
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- Standard9 pagesEnglish and French language
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- Standard16 pagesEnglish and French language
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- Standard18 pagesEnglish and French language
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- Standard21 pagesEnglish and French language
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This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain ...view more
- Technical report43 pagesEnglish language
sale 15% off- Technical report47 pagesFrench language
sale 15% off- Draft43 pagesEnglish language
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- Standard38 pagesEnglish and French language
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This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be ful...view more
- Technical report87 pagesEnglish language
sale 15% off- Technical report87 pagesEnglish language
sale 15% off- Technical report104 pagesFrench language
sale 15% off- Technical report87 pagesEnglish language
sale 15% off
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fu...view more
- Technical report87 pagesEnglish language
sale 15% off