EN 455-3:1999
(Main)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 glove packaging and the disclosure of information relevant to the test methods used. It also contains a review of immunological test methods for the determination of, leachable proteinds and allergens.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfungen für die biologische Bewertung
Dieser Teil der EN 455 legt Anforderungen fu(r die Bewertung der biologischen Sicherheit von medizinischen Einmalhandschuhen fest. Er entha(lt die Anforderung fu(r die Kennzeichnung, die Handschuhverpackung und die Bereithaltung von Informationen u(ber die angewendeten Pru(fmethoden. Er entha(lt außerdem eine Zusammenfassung von immunologischen Methoden zur Bestimmung von lo(slichen Proteinen und Allergenen.
Gants médicaux non réutilisables - Partie 3: Exigences et essais pour évaluation biologique
La présente partie de l'EN 455 spécifie les exigences permettant d'évaluer la sécurité biologique des gants médicaux ` usage unique. Elle mentionne les exigences d'étiquetage et d'emballage des gants ainsi que d'obtention des informations intéressant les méthodes d'essai utilisées. Elle contient également un résumé des méthodes d'essai immunologiques destinées au dosage des protéines extractibles et des allergènes.
Medicinske rokavice za enkratno uporabo - 3.del: Zahteve in preskusi za biološko ovrednotenje
General Information
- Status
- Withdrawn
- Publication Date
- 07-Dec-1999
- Withdrawal Date
- 05-Dec-2006
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 3 - Medical gloves
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 06-Dec-2006
- Completion Date
- 06-Dec-2006
Relations
- Effective Date
- 22-Dec-2008
Frequently Asked Questions
EN 455-3:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical gloves for single use - Part 3: Requirements and testing for biological evaluation". This standard covers: 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 glove packaging and the disclosure of information relevant to the test methods used. It also contains a review of immunological test methods for the determination of, leachable proteinds and allergens.
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 glove packaging and the disclosure of information relevant to the test methods used. It also contains a review of immunological test methods for the determination of, leachable proteinds and allergens.
EN 455-3:1999 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 455-3:1999 has the following relationships with other standards: It is inter standard links to EN 455-3:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-3:1999 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 455-3:1999 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske rokavice za enkratno uporabo - 3.del: Zahteve in preskusi za biološko ovrednotenjeMedizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfungen für die biologische BewertungGants médicaux non réutilisables - Partie 3: Exigences et essais pour évaluation biologiqueMedical gloves for single use - Part 3: Requirements and testing for biological evaluation11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 455-3:1999SIST EN 455-3:2000en01-julij-2000SIST EN 455-3:2000SLOVENSKI
STANDARD
SIST EN
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