دانلود استاندارد AAMI TIR42 Evaluation of particulates associated with vascular medical devices

خرید استاندارد AAMI TIR42 Evaluation of particulates associated with vascular medical devices

کلیه استانداردهاي انجمن پيشبرد ابزار دقيق پزشکي  Evaluation of particulates associated with vascular medical devicesموجود است. برای سفارش استانداردهای AAMI که در سایت اعلام نشده، کافیست شماره استاندارد AAMI درخواستی خود را از طریق یکی از راههای ارتباطی برای ما ارسال کنبد تا PDF استاندارد پس از واریز هزینه اعلامی، ارسال شود.

Download AAMI TIR42 Evaluation of particulates associated with vascular medical devices

این سند در معرض قرار گرفتن در معرض عروق در ذرات ناشی از محیط تولید دستگاه های پزشکی و استفاده از دستگاه های پزشکی است. این TIR در نظر دارد راهنمایی هایی را برای تولید کنندگان دستگاه های پزشکی در استفاده از روش های تحلیلی برای آزمایش ذرات ، شناسایی منابع احتمالی ذرات و ایجاد حدود برای ذرات ارائه دهد.

خرید استاندارد AAMI TIR42 ارزیابی ذرات مرتبط با دستگاههای پزشکی عروقی

AAMI TIR42:2010
Evaluation of particulates associated with vascular medical devices
standard by Association for the Advancement of Medical Instrumentation, 12/13/2010

Published:
12/13/2010
ISBN(s):
1570204039
Number of Pages:
58
File Size:
1 file , 470 KB

https://www.techstreet.com/standards/aami-tir42-2010?product_id=1758986

Full Description AAMI EC12

This document addresses vascular exposure to particles arising from the manufacturing environment for medical devices and from the use of medical devices. This TIR is intended to offer guidance to medical device manufacturers in applying analytical methods for particulate testing, identifying potential sources of particulates, and developing limits for particulates.

فهرست مطالبAAMI TIR42 Evaluation of particulates associated with vascular  medical devices

Contents
Page
Committee representation……………………………………………………………………………………………………………….iv
Foreword……………………………………………………………………………………………………………………………………….v
1 Scope……………………………………………………………………………………………………………………………………..1
1.1 Inclusions………………………………………………………………………………………………………………………1
1.2 Exclusions……………………………………………………………………………………………………………………..1
2 Normative references ……………………………………………………………………………………………………………….1
3 Definitions and abbreviations……………………………………………………………………………………………………..1
4 Requirements ………………………………………………………………………………………………………………………….2
4.1 Labeling requirements …………………………………………………………………………………………………….2
4.2 Performance requirements ………………………………………………………………………………………………2
4.2.1 Packaging and shelf life………………………………………………………………………………………2
4.2.2 Electrical performance………………………………………………………………………………………..3
4.3 Safety requirements………………………………………………………………………………………………………..4
4.3.1 Biological response ……………………………………………………………………………………………4
4.3.2 Pre-attached leadwire safety ……………………………………………………………………………….4
4.4 Adhesive performance (duration of use)…………………………………………………………………………….4
5 Tests ………………………………………………………………………………………………………………………………………4
5.1 Labeling ………………………………………………………………………………………………………………………..4
5.2 Performance ………………………………………………………………………………………………………………….4
5.2.1 Packaging and shelf life………………………………………………………………………………………4
5.2.2 Tests for electrical performance …………………………………………………………………………..4
5.3 Safety……………………………………………………………………………………………………………………………6
5.3.1 Biological response evaluation …………………………………………………………………………….6
5.3.2 Pre-attached leadwire safety ……………………………………………………………………………….6
5.4 Adhesive performance (duration of use)…………………………………………………………………………….7
Annexes
A Rationale for the development and provisions of this standard ……………………………………………………….8
B Cited references …………………………………………………………………………………………………………………….14
Tables
1 Summary of labeling requirements ……………………………………………………………………………………………..2
2 Summary of performance requirements ………………………………………………………………………………………3
Figures
1 Test circuit for offset instability/internal noise determination …………………………………………………………..5
2 Defibrillation overload test circuit (all capacitor and resistor values have a tolerance
of ± 10%) ………………………………………………………………………………………………………………………………..5

کلمات کلیدی :

استاندارد AAMI استاندارد های AAMI پکیج کامل استاندارد AAMI  ، مجموعه کامل استاندارد AAMI ، خرید استاندارد AAMI خرید پکیج استاندارد انجمن تجهیزات پیشرفته پزشکی دانلود استاندارد دانلود استاندارد AAMI دانلود استاندارد AAMI 2019 دانلود رایگان استاندارد AAMI  فروش استاندارد AAMI

دانلود استاندارد AAMI EC12

خرید استاندارد AAMI EC12

AAMI EC12:2000/(R)2015

Disposable ECG electrodes

کلیه استانداردهاي انجمن پيشبرد ابزار دقيق پزشکي |||  Association for the Advancement of Medical Instrumentation موجود است. برای سفارش استانداردهای AAMI که در سایت اعلام نشده، کافیست شماره استاندارد AAMI درخواستی خود را از طریق یکی از راههای ارتباطی برای ما ارسال کنبد تا PDF استاندارد پس از واریز هزینه اعلامی، ارسال شود.

Download AAMI Standard

The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.

Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs).

خرید استاندارد AAMI EC12

AAMI EC12:2000/(R)2015
Disposable ECG electrodes
standard by Association for the Advancement of Medical Instrumentation, 01/06/2005

https://www.techstreet.com/standards/aami-ec12-2000-r-2015?product_id=1642226

Full Description AAMI EC12

This standard establishes contains minimum labeling, safety and performance requirements; test methods; and terminology for disposable electrocardiographic (ECG) electrodes.

فهرست مطالب Disposable ECG electrodes

Contents
Page
Committee representation……………………………………………………………………………………………………………….iv
Foreword……………………………………………………………………………………………………………………………………….v
1 Scope……………………………………………………………………………………………………………………………………..1
1.1 Inclusions………………………………………………………………………………………………………………………1
1.2 Exclusions……………………………………………………………………………………………………………………..1
2 Normative references ……………………………………………………………………………………………………………….1
3 Definitions and abbreviations……………………………………………………………………………………………………..1
4 Requirements ………………………………………………………………………………………………………………………….2
4.1 Labeling requirements …………………………………………………………………………………………………….2
4.2 Performance requirements ………………………………………………………………………………………………2
4.2.1 Packaging and shelf life………………………………………………………………………………………2
4.2.2 Electrical performance………………………………………………………………………………………..3
4.3 Safety requirements………………………………………………………………………………………………………..4
4.3.1 Biological response ……………………………………………………………………………………………4
4.3.2 Pre-attached leadwire safety ……………………………………………………………………………….4
4.4 Adhesive performance (duration of use)…………………………………………………………………………….4
5 Tests ………………………………………………………………………………………………………………………………………4
5.1 Labeling ………………………………………………………………………………………………………………………..4
5.2 Performance ………………………………………………………………………………………………………………….4
5.2.1 Packaging and shelf life………………………………………………………………………………………4
5.2.2 Tests for electrical performance …………………………………………………………………………..4
5.3 Safety……………………………………………………………………………………………………………………………6
5.3.1 Biological response evaluation …………………………………………………………………………….6
5.3.2 Pre-attached leadwire safety ……………………………………………………………………………….6
5.4 Adhesive performance (duration of use)…………………………………………………………………………….7
Annexes
A Rationale for the development and provisions of this standard ……………………………………………………….8
B Cited references …………………………………………………………………………………………………………………….14
Tables
1 Summary of labeling requirements ……………………………………………………………………………………………..2
2 Summary of performance requirements ………………………………………………………………………………………3
Figures
1 Test circuit for offset instability/internal noise determination …………………………………………………………..5
2 Defibrillation overload test circuit (all capacitor and resistor values have a tolerance
of ± 10%) ………………………………………………………………………………………………………………………………..5

کلمات کلیدی :

استاندارد AAMI استاندارد های AAMI پکیج کامل استاندارد AAMI  ، مجموعه کامل استاندارد AAMI ، خرید استاندارد AAMI خرید پکیج استاندارد انجمن تجهیزات پیشرفته پزشکی دانلود استاندارد دانلود استاندارد AAMI دانلود استاندارد AAMI 2019 دانلود رایگان استاندارد AAMI  فروش استاندارد AAMI

دانلود استاندارد AAMI EC53:2013

خرید استاندارد AAMI

کلیه استانداردهاي انجمن پيشبرد ابزار دقيق پزشکي |||  Association for the Advancement of Medical Instrumentation موجود است. برای سفارش استانداردهای AAMI که در سایت اعلام نشده، کافیست شماره استاندارد AAMI درخواستی خود را از طریق یکی از راههای ارتباطی برای ما ارسال کنبد تا PDF استاندارد پس از واریز هزینه اعلامی، ارسال شود.

Download AAMI Standard

The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.

Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs).

خرید استاندارد ANSI/AAMI EC38

ANSI/AAMI EC38:2007
Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, or ambulatory electrocardiographic systems

This standard establishes particular requirements for the safety, including essential performance, or ambulatory electrocardiographic systems that provide continuous recording and analysis of ECG.

https://www.techstreet.com/standards/aami-ec53-2013?product_id=1872879

Full Description AAMI EC38

scope:
Addition:

This Particular Standard specifies the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.

Within the scope of this standard are systems of the following types:

a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit, or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;

b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories.

If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. Medical electrical equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard.

This standard does not apply to systems that do not continuously record and analyze the ECG (for example, ‘intermittent event recorders’).

کلمات کلیدی :

استاندارد AAMI استاندارد های AAMI پکیج کامل استاندارد AAMI  ، مجموعه کامل استاندارد AAMI ، خرید استاندارد AAMI خرید پکیج استاندارد انجمن تجهیزات پیشرفته پزشکی دانلود استاندارد دانلود استاندارد AAMI دانلود استاندارد AAMI 2019 دانلود رایگان استاندارد AAMI  فروش استاندارد AAMI

دانلود استاندارد AAMI EC38

خرید استاندارد AAMI

کلیه استانداردهاي انجمن پيشبرد ابزار دقيق پزشکي |||  Association for the Advancement of Medical Instrumentation موجود است. برای سفارش استانداردهای AAMI که در سایت اعلام نشده، کافیست شماره استاندارد AAMI درخواستی خود را از طریق یکی از راههای ارتباطی برای ما ارسال کنبد تا PDF استاندارد پس از واریز هزینه اعلامی، ارسال شود.

Download AAMI Standard

The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.

Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs).

خرید استاندارد ANSI/AAMI EC38

ANSI/AAMI EC38:2007
Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, or ambulatory electrocardiographic systems

This standard establishes particular requirements for the safety, including essential performance, or ambulatory electrocardiographic systems that provide continuous recording and analysis of ECG.

https://webstore.ansi.org/standards/aami/ansiaamiec382007

Full Description AAMI EC38

scope:
Addition:

This Particular Standard specifies the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.

Within the scope of this standard are systems of the following types:

a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit, or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;

b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories.

If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. Medical electrical equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard.

This standard does not apply to systems that do not continuously record and analyze the ECG (for example, ‘intermittent event recorders’).

کلمات کلیدی :

استاندارد AAMI استاندارد های AAMI پکیج کامل استاندارد AAMI  ، مجموعه کامل استاندارد AAMI ، خرید استاندارد AAMI خرید پکیج استاندارد انجمن تجهیزات پیشرفته پزشکی دانلود استاندارد دانلود استاندارد AAMI دانلود استاندارد AAMI 2019 دانلود رایگان استاندارد AAMI  فروش استاندارد AAMI