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SIST EN 455-3:2015/oprA1:2016

(Amendment)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung

Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologique

Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za biološko ovrednotenje

General Information

Status
Not Published
Public Enquiry End Date
29-Dec-2016
ICS
11.140 - Hospital equipment
Technical Committee
VAZ - Healthcare
Current Stage
98 - Abandoned project (Adopted Project)
Start Date
14-Jan-2020
Due Date
19-Jan-2020
Completion Date
14-Jan-2020
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 455-3:2015/prA1 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

Amends
SIST EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
01-Dec-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 455-3:2015/oprA1:2016
01-december-2016
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za
biološko ovrednotenje
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und
Prüfung für die biologische Bewertung
Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation
biologique
Ta slovenski standard je istoveten z: EN 455-3:2015/prA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-3:2015/oprA1:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 455-3:2015/oprA1:2016

---------------------- Page: 2 ----------------------

SIST EN 455-3:2015/oprA1:2016


DRAFT
EUROPEAN STANDARD
EN 455-3:2015
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
October 2016
ICS 11.140
English Version

Medical gloves for single use - Part 3: Requirements and
testing for biological evaluation
Gants médicaux non réutilisables - Partie 3 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour évaluation biologique Teil 3: Anforderungen und Prüfung für die biologische
Bewertung
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 205.

This draft amendment A1, if approved, will modify the European Standard EN 455-3:2015. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent righ
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

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