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مراجع و فرم‌ها

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IEC

60601-1-2:2020

Medical electrical equipment – Part 1-2: Electromagnetic disturbances – Requirements and tests

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IEC

62366

Application of usability engineering to medical devices

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IEC

62304

Medical device software – Software life cycle processes

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INSO

3001-2

سترونی وسایل پزشکی – قسمت 2: روش صافی غشایی

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INSO

3001-1

سترونی وسایل پزشکی – قسمت 1: روش مستقیم

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INSO

18024

آیین‌کار ارزیابی ضدعفونی‌کننده‌های اتاق تمیز

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ISO

11737-2:2020

Tests of sterility performed in the definition, validation and maintenance of sterilization

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ISO

15223

Symbols to be used with information to be supplied by the manufacturer

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ISO

10993 Series (1,5,10)

Biological evaluation of medical devices

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ISO

13485:2016

Medical devices — Quality management systems

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ISO

14971:2019

Application of risk management to medical devices

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ISO/TR

24971

Guidance on the application of ISO 14971

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ISO

11135:2014

Ethylene oxide — Requirements for validation and routine control

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ISO

11607-1:2020

Requirements for materials, sterile barrier systems and packaging

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ISO

20417:2021

Information to be supplied by the manufacturer

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ISO

19227:2018

Cleanliness of orthopedic implants

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EU

MDR 2017/745

Medical Device Regulation (EU)

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ASTM

F1980-2016

Accelerated Aging of Sterile Barrier Systems

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BS EN

61010-1

Electrical equipment for measurement, control, and lab use

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