I.S. EN ISO 10993-17:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)
Hardcopy , PDF
30-11-2023
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 General principles for establishing allowable limits
5 Establishment of tolerable intake (TI) for specific
leachable substances
5.1 General
5.2 Exposure considerations for TI calculation
5.3 Collection and evaluation of data
5.4 Set TI for noncancer endpoints
5.5 Set TI for cancer endpoints
5.6 Establishment of tolerable contact levels (TCLs)
5.7 Risk assessment of mixtures
6 Calculation of tolerable exposure (TE)
6.1 General
6.2 Exposure population
6.3 Calculation of utilization factor from intended
use pattern
6.4 Tolerable exposure
7 Feasibility evaluation
8 Benefit evaluation
9 Allowable limits
10 Reporting requirements
Annex A (informative) - Some typical assumptions for
biological parameters
Annex B (informative) - Risk assessment for mixtures
of leachable substances
Annex C (informative) - Conversion of allowable limits
for systemic exposure and for body surface
contact to maximum dose to patient from a
medical device
Annex D (informative) - Risk analysis report
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
Describes a method for the determination of allowable limits for substances leachable from medical devices.
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN ISO 10993-17:2009 | Identical |
| NBN EN ISO 10993-17 : 2009 | Identical |
| UNI EN ISO 10993-17 : 2009 | Identical |
| BS EN ISO 10993-17:2009 | Identical |
| SN EN ISO 10993-17 : 2009 | Identical |
| EN ISO 10993-17:2009 | Identical |
| DIN EN ISO 10993-17:2009-08 | Identical |
| NS EN ISO 10993-17 : 2009 | Identical |
| NF EN ISO 10993-17 : 2009 | Identical |
| ISO 10993-17:2002 | Identical |
| NEN EN ISO 10993-17 : 2009 | Identical |
| ONORM EN ISO 10993-17 : 2009 | Identical |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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