Product Classification

• Device: gas-machine, anesthesia
• Regulation Description: Gas machine for anesthesia or analgesia.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BSZ
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.5160
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 1-62 ISO 5356-1 Third edition 2004-05-15
  Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
• 1-81 CGA V-5:2008 (Reaffirmed 2013)
  Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
• 1-101 CGA C-9:2013
  Standard Color Marking of Compressed Gas Containers for Medical Use
• 1-114 ISO 18835 First Edition 2015-04-01
  Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
• 1-116 ISO 5360 Fourth edition 2016-02-15
  Anaesthetic vaporizers - Agent specific filling systems
• 1-124 ISO 8835-7 First edition 2011-11-01
  Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
• 1-129 ISO 5359 Fourth edition 2014-10-01
  Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
• 1-134 ISO 18562-1 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-135 ISO 18562-2 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-136 ISO 18562-3 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 1-137 ISO 18562-4 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
• 1-141 ISO 80601-2-13 First edition 2011-08-11
  Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
• 1-165 ISO 80601-2-13 Second edition 2022-04
  Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
• 1-167 CGA V-5:2019
  Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
• 1-170 CGA C-9:2019
  Standard Color Marking of Compressed Gas Containers for Medical Use
• 1-173 ISO 18562-1 Second edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-174 ISO 18562-2 Second edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-175 ISO 18562-3 Second Edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 1-176 ISO 18562-4 Second Edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

Third Party Review

Not Third Party Eligible