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AAMI TIR14:2016

Contract sterilization using ethylene oxide

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract ster
Price: $119.00
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AAMI TIR29:2012 (AAMI TIR 29:2012)

Technical Information Report Guide for process characterization and control in radiation sterilization of medical devices

This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control req
Price: $196.00
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AAMI TIR40:2009 (R2016)

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2

This technical information report describes the approach for establishing a sterilization dose utilizing a modification of the fraction positive, incremental dosing method defined in Method 2 of ANSI/
Price: $148.00
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AAMI TIR55:2014 (AAMI TIR 55:2014)

Human factors engineering for processing medical devices

This document provides guidance to medical device manufacturers from a human factors perspective on the aspects of product design; design of processing instructions for use (IFU); education and traini
Price: $140.00
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AAMI TIR56:2013 (R2016)

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas di
Price: $183.00
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AAMI TIR66:2017

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

Provides guidance to manufacturers that change existing or create new alarm systemalgorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the alg
Price: $183.00
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AAMI/CN3:2014

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (provisional American National Standard)

This is a PDF copy of AAMI/CN3:2014, a provisional American National Standard. Purchasers of this standard will receive a PDF copy of ANSI/AAMI/ISO 80369-3 (pending approval of the ISO/FDIS ballot), w
Price: $195.00
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AAMI/IEC TIR80001-2-8:2016

Technical Information Report - Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

This technical report provides guidance for the application of the framework outlined in AAMI/IEC 80001-2-2. Managing the RISK in connecting MEDICAL DEVICES to IT-networks requires the disclosure of s
Price: $222.00
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ANSI ASC A14.3 / ANSI/ASSE A1264.1 - Safety requirements for Fixed Ladders and Workplace Surfaces Package

ANSI ASC A14.3 and ANSI/ASSE A1264.1

ANSI ASC A14.3 / ANSI/ASSE A1264.1 - Safety requirements for Fixed Ladders and Workplace Surfaces Package provides the safety requirements designed to prevent personal injuries which can occur in indu
Price: $340.00
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ANSI C12.18-2006 (R2016)

Protocol specification for ansi type 2 optical port

Details the criteria required for communications between a C12.18 device and a C12.18 client via an optical port. The C12.18 client may be a handheld reader, a portable computer, a master station syst
Price: $103.00
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