• There are no items in your cart

ASTM F 2761 : 2009 : R2013

Current

Current

The latest, up-to-date edition.

Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-10-2013

This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6.

Committee
F 29
DocumentType
Guide
Pages
39
PublisherName
American Society for Testing and Materials
Status
Current

This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used MEDICAL DEVICES.

This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT.

This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance. NOTE These requirements were derived to support the clinical scenarios or clinical concepts of operations described in Annex B.

BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
15/30328959 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
UNI EN ISO 80601-2-61 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
09/30203808 DC : 0 BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
16/30346073 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
BS EN ISO 80601-2-12:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BS EN ISO 80601-2-61:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment
AAMI TIR38 : 2015 MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE
EN ISO 80601-2-13:2012 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
BS EN ISO 80601-2-13:2012 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
BS EN ISO 80601-2-72:2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
UNI EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
CSA C22.2 No. 80601-2-61 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
CSA C22.2 No. 80601-2-12 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
UNE-EN ISO 80601-2-13:2013 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
I.S. EN ISO 80601-2-13:2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011)
EN ISO 80601-2-55:2018 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
ISO 80601-2-55:2018 Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
CSA C22.2 No. 80601-2-12 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
13/30264413 DC : 0 BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
I.S. EN ISO 80601-2-72:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
I.S. EN ISO 80601-2-12:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-72:2015 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
UNI EN ISO 80601-2-13 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
EN ISO 80601-2-72:2015 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
I.S. EN ISO 80601-2-61:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
16/30316718 DC : 0 BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
16/30312315 DC : 0 BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
I.S. EN ISO 80601-2-55:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
BS EN ISO 80601-2-13:2012+A2:2019 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
ISO/IEC 7498-1:1994 Information technology Open Systems Interconnection Basic Reference Model: The Basic Model
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 11990:2003 Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization

€96.91
Excluding VAT

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.