15/30278530 DC : 0

Superseded

BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

Available format(s)

Hardcopy , PDF

Superseded date

31-03-2017

Language(s)

English

Publisher

British Standards Institution

Foreword
European Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to BIOCOMPATIBILITY
  evaluation of MEDICAL DEVICES
5 Contamination of breathing gas from GAS PATHWAYS
6 Adjustment for different PATIENT groups
7 Deriving allowable limits
8 Adjustment of TOLERABLE EXPOSURE for benefit
  of the treatment
9 Assess the BIOCOMPATIBILITY of the MEDICAL DEVICE
Annex A (informative) - Rationale and guidance
Annex B (informative) - Reference to the Essential Principles
Annex C (informative) - Terminology - alphabetized index
        of defined terms
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements of EU Directive 93/42/EEC
Bibliography

BS ISO 18562-1.

Committee	CH/121/9
DocumentType	Draft
Pages	36
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 18562-1:2017

BS 5724-3.12:1991	Medical electrical equipment. Particular requirements for performance Method of declaring parameters for lung ventilators
EN ISO 10993-17:2009	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
ASTM D 5466 : 2015 : REDLINE	Standard Test Method for Determination of Volatile Organic Compounds in Atmospheres (Canister Sampling Methodology)
ISO 80601-2-12:2011	Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 8185:2007	Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO 10993-18:2005	Biological evaluation of medical devices Part 18: Chemical characterization of materials
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
EN ISO 10993-18:2009	Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 16000-6:2011	Indoor air Part 6: Determination of volatile organic compounds in indoor and test chamber air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using MS or MS-FID
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO/TR 15499:2016	Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process