iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN 455-3:2015/prA1

(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
Publication Date
03-Jun-2018
ICS
11.140 - Hospital equipment
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205/WG 3 - Medical gloves
Current Stage
3098 - Decision to reject - Consensus building
Completion Date
12-Dec-2019
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
SIST EN 455-3:2015/oprA1:2016 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

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

Buy Standard

EN 455-3:2015/oprA1:2016EN 455-3:2015/oprA1:2016
PreviousNext
Draft
EN 455-3:2015/oprA1:2016
English language
4 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

This May Also Interest You

CEN
EN 455-1:2020+A2:2024(Main)
Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
SIST EN 455-1:2020+A2:2024

This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

  • Standard
    10 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 455-2:2024(Main)
Medical gloves for single use - Part 2: Requirements and testing for physical properties
SIST EN 455-2:2024

This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 455-3:2023(Main)
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
SIST EN 455-3:2024

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.

  • Standard
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 14683:2019+AC:2019(Main)
Medical face masks - Requirements and test methods
SIST EN 14683:2019+AC:2019

This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1   Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2   Annex A provides information for the users of medical face masks.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13795-2:2019(Main)
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
SIST EN 13795-2:2019

This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

  • Standard
    29 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13795-1:2019(Main)
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
SIST EN 13795-1:2019

This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.
EN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810.
EN 13795-1 does not cover requirements for incise drapes or films.
EN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.

  • Standard
    33 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TR 16953:2017(Main)
Medical gloves for single use - Guidance for selection
SIST-TP CEN/TR 16953:2018

This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination.
NOTE   Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5.
This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.

  • Technical report
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 455-4:2009(Main)
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
SIST EN 455-4:2009

for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

  • Standard
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21171:2006(Main)
Medical gloves - Determination of removable surface powder (ISO 21171:2006)
SIST EN ISO 21171:2006

ISO 21171:2006 specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specified: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International Standard to medical gloves not made from rubber has not been established.

  • Standard
    17 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 22612:2005(Main)
Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
SIST EN ISO 22612:2005

ISO 22612:2005 specifies a test method for assessing the resistance to penetration through barrier materials of bacteria-carrying particles.
Due to its complexity, this ISO 22612:2005 cannot be considered as a useful method for routine quality control but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as EU Directive 93/42/EEC.

  • Standard
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day