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Standard ČSN EN 50077 1.6.1995 preview

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ČSN EN 50077 (364816)

Low-profile connector for implantable cardiac pacemakers



STANDARD published on 1.6.1995


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The information about the standard:

Designation standards: ČSN EN 50077
Classification mark: 364816
Catalog number: 17586
Publication date standards: 1.6.1995
SKU: NS-153781
The number of pages: 16
Approximate weight : 48 g (0.11 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Implants for surgery, prosthetics and orthotics

Annotation of standard text ČSN EN 50077 (364816):

Norma obsahuje EN 50077:1993. Specifikuje sestavu konektoru, používanou k připojení vodičů implantabilních stimulačních elektrod k implantabilním pulzním generátorům. Jsou stanoveny hlavní požadavky na rozměry a funkci, včetně příslušných zkušebních metod. Nicméně, norma se nezabývá všemi hledisky funkční kompatibility a spolehlivosti různých vodičů stimulačních elektrod a pulzních generátorů, tvořících stimulační systém. Zejména norma nestanovuje určité hlavní charakteristiky, jakými jsou např. prostředky k upevnění sestavy konektoru nebo konstrukční materiály. Výstraha: Dutinka konektoru podle této normy se nemá používat u těch implantabilních zařízení, kde lze přes konektor IS-1 převést nebezpečné signály, neurčené ke stimulaci (např. defibrilační). Touto evropskou normou se doplňuje ČSN EN 50061 pouze pro ty prvky kardiostimulátorů, které jsou podle štítku vybaveny částí sestavy konektoru IS-1. Nenahrazují se žádné požadavky ČSN EN 50061, souvisící s vodiči stimulačních elektrod. ČSN EN 50077 (36 4816) byla vydána v červnu 1995

Preview of the standard ČSN EN 50077 (364816)

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