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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)
Hardcopy , PDF
11-30-2023
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.
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
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.