EN ISO 11607-2 pdf download
EN ISO 11607-2 pdf download Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) Scope This part of ISO 11607 specifies the requirements for development and validation of processes for packagingmedical devices that are terminally sterilized. These processes include forming, sealing, and assembly otpreformed sterile barrier systems, sterile barrier systems...
EN ISO 14644-5 pdf download
EN ISO 14644-5 pdf download Cleanrooms and associated controlled environments – Part 5: Operations (ISO 14644-5:2004) Scope This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644...
EN ISO 17511 pdf download
EN ISO 17511 pdf download In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)、Scope This European Standard specifies how to assure the metrological traceability of values assigned to calibrators andcontrol materials intended to establish or verify trueness of measurement. The calibrators and control materials...
EN ISO 17664 pdf download
EN ISO 17664 pdf download Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices 1 Scope This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. This...
EN ISO 17665-1 pdf download
EN ISO 17665-1 pdf download Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665- 1:2006) 1 Scope 1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for...
ISO 4666-4 pdf download
ISO 4666-4 pdf download Rubber, vulcanized — Determination of temperature rise and resistance to fatigue in flexometer testing — Part 4: Constant-stress flexometer Scope This part of ISO 4666 specifies a constant-stress flexometer test for the determination of the temperature riseand resistance to fatique of vulcanized rubbers. Many rubber products, such as tyres and belts, are tested by subjecting them...
ISO 4832 pdf download
ISO 4832 pdf download Microbiology of food and animal feeding stuffs — Horizontal method for the enumeration of coliforms — Colony-count technique 1 Scope This International Standard gives general guidelines for the enumeration of coliforms. It is applicable to — products intended for human consumption and for the feeding of animals, and — environmental samples in the area of food...
ISO 4992-2 pdf download
ISO 4992-2 pdf download Steel castings — Ultrasonic examination — Part 2: Steel castings for highly stressed components 1 ScopeThis part of ISO 4992 specifies the requirements for the ultrasonic examination of steel castings (with ferriticstructure) for highly stressed components, and the methods for determining internal discontinuities by the pulseecho technique. This part of ISO 4992 applies to the ultrasonic...
ISO 12151-5 pdf download
ISO 12151-5 pdf download Connections for hydraulic fluid power and general use — Hose fittings — Part 5: Hose fittings with ISO 8434-2 37° flared ends This part of ISO 12151 specifies the general and dimensional requirements for the design and performance of37° flared hose fittings in accordance with ISO 8434-2, made of carbon steel, for nominal hose sizes of6,3...
ISO 14096-2 pdf download
ISO 14096-2 pdf download Non-destructive testing — Qualification of radiographic film digitisation systems — Part 2: Minimum requirements 1 Scope This European Standard specifies three film-digitisation quality classes for the requirements of non-destructive testing. The selected class depends on the radiation energy, penetrated material thickness and the quality level of the original radiographic film. This European Standard does not address...