Name: UNI EN ISO 10993-18 : 2009
Brand: UNI

UNI EN ISO 10993-18 : 2009

Superseded

View Superseded by

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS

Superseded date

26-08-2022

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterization procedure
  6.1 General
  6.2 Step 1 - Qualitative information
  6.3 Step 2 - Material equivalence
  6.4 Step 3 - Quantitative information
  6.5 Step 4 - Quantitative risk assessment
  6.6 Step 5 - Estimated clinical exposure to chemicals
                present
7 Chemical characterization parameters and methods
  7.1 General
  7.2 Polymers
  7.3 Metals and alloys
  7.4 Ceramics
  7.5 Natural macromolecules
8 Reporting of data obtained
Annex A (normative) Flowchart summarizing the stepwise
         generation of chemical characterization data for
         use in toxicological risk assessment
Annex B (informative) Information sources for chemical
         characterization
Annex C (informative) Principles for judging toxicological
         equivalency
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
Bibliography

Describes a framework for the identification of a material and the identification and quantification of its chemical constituents.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 10993-18:2021
Supersedes	UNI EN ISO 10993-18 : 2005

Standards	Relationship
SN EN ISO 10993-18 : 2009	Identical
BS EN ISO 10993-18:2009	Identical
NS EN ISO 10993-18 : 2009	Identical
NF EN ISO 10993-18 : 2009	Identical
DIN EN ISO 10993-18:2009-08	Identical
EN ISO 10993-18:2009	Identical
ISO 10993-18:2005	Identical
NBN EN ISO 10993-18 : 2009	Identical
ONORM EN ISO 10993-18 : 2009	Identical
UNE-EN ISO 10993-18:2009	Identical
I.S. EN ISO 10993-18:2009	Identical
NEN EN ISO 10993-18 : 2009	Identical
DIN EN ISO 10993-18 E : 2009	Identical

EN 12442-3 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
ISO 5725-1:1994	Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 5832-1:2016	Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
ISO 10993-13:2010	Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ISO 10993-14:2001	Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
EN 12442-1 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 12442-2 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING