Số hiệu tiêu chuẩn
prEN ISO 11607-2
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 2: Requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2004)
Ngày phát hành
2004-04-00
Tiêu chuẩn tương đương
DIN EN ISO 11607-2 (2004-07), IDT * 04/30101215 DC (2004-04-23), IDT * S98-052-2, IDT * ISO/DIS 11607-2 (2004-04), IDT * OENORM EN ISO 11607-2 (2004-08-01), IDT
Từ khóa
Definitions * Design * Disposables * Forming * Marking * Materials specification * Medical devices * Medical products * Packages * Packaging material * Performance * Physical testing * Public health * Qualifications * Quality * Quality assurance * Reuse * Sampling methods * Sealing * Shaping * Specification * Specification (approval) * Sterile barrier systems * Sterility * Testing * Tests * Validation * Visual inspection (testing)