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 |
ASTM D573-04 | 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 |
EN 1149-1/2/3 & 5 | Protective clothing – Electrostatic properties |
EN 374-1:1994 | Protective gloves against chemicals & micro-organisms – Terminology and Performance Requirements – 1994 |
EN 374-1:2003 | Protective gloves against chemicals & micro-organisms – Terminology and Performance Requirements – 2003 |
EN 374-2:1994 | Protective gloves against chemicals & micro-organisms – Determination of resistance to penetration – 1994 |
EN 374-2:2003 | Protective gloves against chemicals & micro-organisms – Determination of resistance to penetration – 2003 |
EN 374-2:2014 | Protective gloves against chemicals & micro-organisms- Determination of resistance to penetration – 2014 |
EN374-3 1994 | Protective gloves against chemicals & micro-organisms – Determination of resistance to permeation – 1994 |
EN 374-3:2003 | Protective gloves against chemicals & micro-organisms – Determination of resistance to permeation – 1994 |
EN 388:1994 | Protective gloves against mechanical risks – 1994 |
EN 388:2003 | Protective gloves against mechanical risks – 2003 |
EN 420:1994 | Protective gloves – General requirements and test methods – 1994 |
EN 420:2003 + A1:2009 | Protective gloves – General requirements and test methods – 2003 |
EN 455-1:2000 | Medical gloves for single use – Part 1: Requirements and testing for freedom from holes |
EN 455-2:2015 | Medical gloves for single use – Part 2: Requirements and testing for physical properties |
EN 455-3:2015 | Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
EN 455-4:2009 | 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 16604:2004 | 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
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