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

S.R. CEN TR 15640:2007

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
Available format(s)

Hardcopy , PDF

Withdrawn date

08-12-2017

Language(s)

English

Published date

01-01-2007

Publisher

National Standards Authority of Ireland

Preview

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Symbols and abbreviations
4 Outline of the issues
5 General position on medical device controls
6 The border between health software products and
   medical devices
7 Classifying health software products
8 Options for control measures for health software
   products
9 Standards specific to risks of a particular nature
10 Observation on safety and risks in the user domain
11 Taxonomies
12 Summary of conclusions
Annex A (informative) - Position regarding medical
        devices in different countries
Annex B (informative) - Analysis of classification
        procedures
Annex C (informative) - Risk management
Bibliography

Provides control measures required to ensure patient safety in respect to health software products.

DevelopmentNote
Issue date: 21/05/2011. (06/2011)
DocumentType
Standard
Pages
46
PublisherName
National Standards Authority of Ireland
Status
Withdrawn

Standards Relationship
CEN/TR 15640:2007 Identical

ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 61508-5:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508)
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
PD 6668:2000 MANAGING RISK FOR CORPORATE GOVERNANCE
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO/TS 19218:2005 Medical devices Coding structure for adverse event type and cause
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
AS/NZS 4360:2004 Risk management
ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
ISO 9001:2015 Quality management systems — Requirements
ISO/IEC TR 15271:1998 Information technology Guide for ISO/IEC 12207 (Software Life Cycle Processes)
CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software

View more information
$136.38
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