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SK SSH/EN/ISO 10993-18:2024

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SK SSH/EN/ISO 10993-18:2024
Status: Published
Gjuha: English
Faqe: 88
Publikuar: 2024-09-26
Regjistri Kombëtar: 559/2024
Botim:
Standardet ndërkombëtare që kanë lidhje
This standard is identical to:
EN ISO 10993-18:2020
CEN/TC 206
This standard is identical to:
ISO 10993-18:2020
ISO/TC 194
This standard is identical to:
SSH EN ISO 10993-18:2020
Çmim: 48 €



Titulli Shqip

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 18: Karakterizimi kimik i materialeve të pajisjeve mjekësore brenda procesit të menaxhimit të riskut (ISO 10993-18:2020)

Titulli Anglisht

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction (medical device configuration); — the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); — the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact). This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Komitetet Teknike

ICS

Direktivë

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Veprim Kombëtar

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Numri Standardit
Gjuha
Status
Publikuar
Faqe
Çmim
 
Blej
English
Published 
2022-02-16 
55 
38 € 
PDF
Blej
Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 1: Vlerësimi dhe testimi brenda procesit të menaxhimit të riskut (ISO 10993-1:2018, duke përfshirë versionin e korrigjuar 2018-10)
English
Published 
2024-09-26 
20 
23 € 
PDF
Blej
Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 18: Karakterizimi kimik i materialeve të pajisjeve mjekësore brenda procesit të menaxhimit të riskut - Amendamenti 1: Përcaktimi i faktorit të pasigurisë ISO 10993-18:2020/Amd 1:2022)