Technical Specifications; Standards Compliance - Philips Lifeline Instructions For Use Manual

Technical Specifications

Standards Compliance

This device is designed to conform to the following standards:
• IEC/ANSI/ AAMI60601-1:2005/R(12)2012, 3rd edition, Part 1- General requirements for basic
safety and essential performance.'
• CSA C22.2 # 60601-1:2014 Ed.3 Medical Electrical Equipment - Part 1: General Requirements
For Basic Safety And Essential Performance.
• IEC/UL/CSA 60601-1, 2nd Edition (2003), 'Medical Electrical Equipment, Part 1: General
Requirements for Safety' (except for 7100MHB).
IEC 62133, Safety requirements for portable sealed secondary cells, and for batteries made from
them, for use in portable applications.
• IEC 60601-1-2, 3rd Edition (2007-03), General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests
• IEC 60601-1-4, 2nd Edition (2000), 'Collateral standard: Programmable Electrical Medical
Systems' (except for 7100MHB)
• IEC 62366, 1st Edition (2015), 'Medical devices – Application of usability engineering to medical
devices'
• IEC 60601-1-6, 2nd Edition (2004), 'Collateral standard: Usability' (except for 7100MHB)
• IEC 60601-1-6, 3rd Edition (2013), 'Collateral standard: Usability'
• IEC 60601-1-8, 2nd Edition (2006), 'Collateral standard: General requirements, tests and guidance for
alarm systems in medical electrical equipment and medical electrical systems'
• IEC 60601-1-11, 2nd Edition (2015) 'Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment'
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
(Biocompatibility)
• ISO 14971, 2nd Edition (2007), 'Medical devices – Application of risk management to medical
devices'
• CSA C22.2 No. 205-12 (2012), Signal Equipment(Canada).
• CFR47 FCC Part 15 Subpart B, Sections15.207 & 15.209;
• CFR47 FCC Part 15 Subpart C, Section 15.247.
• CFR47 FCC Part 15 Subpart E.
• RSS-210 Licence - Exempt Radio Apparatus: Category I Equipment
• RSS-247; Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence-
Exempt Local Area Network (LE-LAN) Devices.
• RSS-GEN General Requirements for Compliance of Radio Apparatus (Canada)
• ICES 003 Information Technology Equipment (Including Digital Apparatus) — Limits and Methods
of Measurement (Canda)