Page 4 - ERMIS Container

Regulatorisches
Regulatory

German and European Standards:

DIN EN 868-2: Packaging materials and systems for sterilized medical devices –
Part 2: Sterilization packaging; requirements and test methods

DIN EN 868-8: Packaging materials and systems for sterilized medical devices –
Part 9: Reusable sterilization containers for steam sterilizers conforming to EN 285;
requirements and test methods

DIN EN ISO 11607-1: Packaging for terminally sterilized medical devices –
Part 1: Requirements for materials, sterile barrier systems, and packaging systems
DIN 58952-2: Sterilization; Packaging for sterilized goods, sterilization baskets
made of metal

DIN 58952-3: Sterilization; Packaging for sterilized goods, sterilization trays
made of metal

DIN 58953-9: Sterilization; Supply of sterilized goods –
Part 9: Technical application of sterilization containers

DIN EN ISO 14937: Sterilization of health care products – General requirements for
characterization of a sterilizing agent and development, validation, and routine
control of a sterilization process for medical devices

DIN EN ISO 17665-1: Sterilization of health care products – Moist heat –
Part 1: Requirements for the development, validation, and control of a sterilization
process for medical devices

American Technical Standards:

ANSI AAMI ST77: Containment Devices for Reusable Medical Device Sterilization
AAMI ANSI ST79: Comprehensive Guide to Steam Sterilization and Sterility
Assurance in Health Care Facilities
ASTM 98 (AAMI TIR30): A Compendium of Processes, Materials, Test Methods,
and Acceptance Criteria for Cleaning Reusable Medical Devices
ASTM A240M: Standard Specification for Chromium and Chromium-Nickel
Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and General Applications.

Aktuelle Zertifikate und AGB
https://www.ermis-medizintechnik.de/download/alb-agb
Current Certificates,General Terms and Conditions
https://www.ermis-medizintechnik.de/download-1/general-terms-and-conditions

Bei den angebotenen Produkten kann es sich um ERMIS eigene Ware
wie auch um Handelsware handeln.
The offered products can be concerned as Ermis´s own product as well as trading products.
Unsere Lieferungen und Leistungen richten sich an Unternehmer im Sinne des § 14 BGB,
nicht an Endverbraucher im Sinne § 13 BGB.
Our deliveries and services are directed at entrepreneurs within the meaning of § 14 BGB (German Civil Code),
not at end consumers within the meaning of § 13 BGB.

Unser Unternehmen vertreibt keine Produkte der Aesculap AG und steht mit dieser in keinerlei organisatorischer (lizenz- oder gesellschaftsrechtlicher) Beziehung.

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