Customer Support: 131 242

i2i Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

BS EN 62304 : 2006

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
Amended by

BS EN 62304:2006+A1:2015

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2006

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Software development process
6 Software maintenance process
7 Software risk management process
8 Software configuration management process
9 Software problem resolution process
Annex A (informative) - Rationale for the requirements of
        this standard
Annex B (informative) - Guidance on the provisions of
        this standard
Annex C (informative) - Relationship to other standards
Annex D (informative) - Implementation
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives
Bibliography

Specifies the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.

Committee
CH/62/1
DevelopmentNote
Supersedes 04/30089749 DC (11/2006) 2006 Edition Re-Issued in November 2015 & incorporates AMD 1 2015. 2006 Edition along with its corrigendum is still active & will be withdrawn on 31/07/2018. Supersedes 14/30287753 DC. (11/2015)
DocumentType
Standard
Pages
88
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
NBN EN 62304 : 2007 Identical
EN 62304:2006/A1:2015 Identical
DIN EN 62304 : 2016 Identical
IEC 62304:2006+AMD1:2015 CSV Identical
I.S. EN 62304:2006 Identical
UNE-EN 62304:2007 Identical
NF EN 62304 : 2006 AMD 1 2018 Identical

BS PAS 277(2015) : 2015 HEALTH AND WELLNESS APPS - QUALITY CRITERIA ACROSS THE LIFE CYCLE - CODE OF PRACTICE

EN 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements
ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
ISO/IEC 25010:2011 Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO/IEC 33001:2015 Information technology Process assessment Concepts and terminology
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/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
ISO 9001:2015 Quality management systems — Requirements
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
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
ISO/IEC 33004:2015 Information technology Process assessment Requirements for process reference, process assessment and maturity models

View more information
$549.02
Including GST where applicable
AUD
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

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more