Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search
Home
BSI
BS EN 60601-1-10 : 2008

BS EN 60601-1-10 : 2008

Current

Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS

Amended by

BS EN 60601-1-10:2008+A1:2015

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2008

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
6 Accuracy of controls and instruments and protection against
  hazardous outputs
7 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC)
  development
Annex A (informative) - General guidance and rationale
Annex B (informative) - Description of dynamic performance of a PCLCS
Annex C (informative) - Guide to marking and labelling requirements
        for ME EQUIPMENT and ME SYSTEMS
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives
Bibliography
Index of defined terms used with this collateral standard

Pertains to the BASIC SAFETY a nd ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

Committee
CH/62/1
DevelopmentNote
Supersedes 06/30147232 DC. (09/2008) 2008 Edition remains active & will be withdrawn on 31/12/2018. 2008 Edition Re-Issued in June 2015 & incorporates AMD 1 2015. Supersedes 12/30271196 DC. (07/2015)
DocumentType
Standard
Pages
44
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
IEC 60601-1-10:2007+AMD1:2013 CSV Identical
EN 60601-1-10:2008/A1:2015 Identical

IEC GUIDE 109:2012 Environmental aspects - Inclusion in electrotechnical product standards
IEC 60050-351:2013 International Electrotechnical Vocabulary (IEV) - Part 351: Control technology
EN ISO 14021:2016 Environmental labels and declarations - Self-declared environmental claims (Type II environmental labelling) (ISO 14021:2016)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 14021:2016 Environmental labels and declarations — Self-declared environmental claims (Type II environmental labelling)
EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
EN ISO 14040:2006 Environmental management - Life cycle assessment - Principles and framework (ISO 14040:2006)
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO/TR 14062:2002 Environmental management Integrating environmental aspects into product design and development
ISO 14001:2015 Environmental management systems — Requirements with guidance for use
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
EN ISO 14001:2015 Environmental management systems - Requirements with guidance for use (ISO 14001:2015)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)

View more information
US$261.13
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us