Liste der Handschuh Direktiven und Normen

Richtlinien und Normen

Titel

ANSI/AAMI/EN ISO 11137:2006

Gamma Sterilization Dose Auditing

ASTM D257-07

Standard Test Methods for DC Resistance or Conductance of Insulating Materials

ASTM D257-36

Standard Test Methods for DC Resistance or Conductance of Insulating Materials

ASTM D3578-05

Standard Specification for Rubber Examination Gloves

ASTM D3767-03

Standard Practice for Rubber—Measurement of Dimensions

ASTM D412-06ae2

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

ASTM D5712-10

Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

ASTM D6124-06

Standard Test Method for Residual Powder on Medical Gloves

ASTM D6319-10

Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6978-05

Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ASTM F1671-97b

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

ASTM F720-81

Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

ASTMD573-04

Standard Test Method for Rubber—Deterioration in an Air Oven

Directive 72/2002/EC

relating to plastic materials and articles intended to come into contact with foodstuffs

Directive 89/686/EEC

The Personal Protective Equipment (PPE) EEC Directive

Directive 93/42/EEC

The Medical Devices (MD) EEC Directive

EC 1935/2004

Directive on materials and articles intended to come into contact with food

EN1149-1/2/3 & 5

Protective clothing – Electrostatic properties

EN374-1:1994

Protective gloves against chemicals & micro-organisms – Terminology and Performance Requirements – 1994

EN374-1:2003

Protective gloves against chemicals & micro-organisms – Terminology and Performance Requirements – 2003

EN374-2:1994

Protective gloves against chemicals & micro-organisms – Determination of resistance to penetration – 1994

EN374-2:2003

Protective gloves against chemicals & micro-organisms – Determination of resistance to penetration – 2003

EN374-3 1994

Protective gloves against chemicals & micro-organisms – Determination of resistance to permeation – 1994

EN374-3:2003

Protective gloves against chemicals & micro-organisms – Determination of resistance to permeation – 1994

EN388:1994

Protective gloves against mechanical risks – 1994

EN388:2003

Protective gloves against mechanical risks – 2003

EN420:1994

Protective gloves – General requirements and test methods – 1994

EN420:2003+A1:2009

Protective gloves – General requirements and test methods – 2003

EN455-1:2000

Medical gloves for single use – Part 1: Requirements and testing for freedom from holes

EN455-2:2015

Medical gloves for single use – Part 2: Requirements and testing for physical properties

EN455-3:2015

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

EN455-4:2009

Medical gloves for single use – Part 4: requirements and testing for shelf life determination

FDA 21CFR177.2600

FDA – Food for Human Consumption – Indirect Food Additives: Polymers – Rubber article intended for repeated use

IEST-RP-C005.3

Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments

ISO 13485:2003

Medical devices – Quality management systems — Requirements for regulatory purposes

ISO 16 604

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

ISO 21171:2006

Medical gloves – Determination of removable surface powder

ISO 9001:2008

Quality management systems — Requirements

* List of applicables norms and regulations for nitrile gloves, latex gloves, laboratory gloves and cleanroom gloves