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Medical Compliance
- FDA The food and drug administration regulates the manufacture and marketing of medical devices in the USA. Recommends testing to IEC 60601 2nd/3rd edition series as part of a 510(k). The FDA does not approve 510k notifications. Rather, the agency makes a determination of whether the device is substantially equivalent to devices already on the market.
- 510(K)s' Premarket notifications
- PMA - Premarket Approval Applications
- PMA Supplements - Application to modify a device which is already approved through the PMA process.
- Medical Equipment Evaluation
- Conduct and Prepare Risk Assessment Investigation.
- Identify your product Hazards.
- Define the Risks, the Potential Harm, the Severity and Likelihood of injury.
- Identify product Pinch, Gap and Sear Points
- Entrapment: 60601-2-38, 60601-2-52, HBSW.
- Discuss Anthropomorphic Data for Bariatric patient devices.
- Prepare Risk Management Documentation:
- Review Installation and Operation instructions.
- Discuss Intended usage, Reasonable Misuse and Abuse.
- Usability. Establish a process to provide for the safety of the patient, user and others.
- Discus meeting "State of the Art".
- Discuss Client Risk management experience (Market Research, Clinical Trials).
- Provide client consulting in making Risk Acceptance decisions.
- Risk Mitigation: Apply management policies, procedures and practices to minimize risks.
- Develop ISO/IEC 14971 documentation.
- Product Construction
- Define degration of product and Review Essential Performance under Single Fault Conditions.
- Discuss Temperatures, Overflow, Spillage, Fluid leakage, Cleaning, Sterilization, and construction of ME Equipment.
- Fire Enclosure and Flammability.
- Oxygen Compatibility.
- Stability and Mobility.
- Enclosure rigidity.
- Noise and Vibration.
- Components
- Researching and using High Integrity Components.
- Component Conditions of Acceptability.
- NRTL Recognized Components.
- Split Inspection for Unrecognized components.
- CB Scheme component licences.
- Power Supply and Transformer Issues.
- Insulation Coordination.
- Means of Protection.
- Creepage and Clearance.
- Prepare Insulation Diagram: Drawing showing BOP, BI, SI, RI, DI circuits.
- Dielectric Testing.
- Prepare Test plan for achieving conformance to 60601-1 2nd and 3rd Editions.
- Discuss Medical Equipment Systems, environment and other equipment.
- Selection of particular tests.
- Applied Parts and Leakage Currents.
- Modification of specific tests for Outdoor use.
- Pass/Fail criteria.
- Safety Testing: Electrical, Mechanical, Biocompatibility, Cleaning.
- Ingress Protection: IPX Rating System and Test.
- Marking and Documentation
- Ratings Label Information.
- Graphics and symbols.
- Safety Signs (color ISO 3864-1).
- Indicator Lights (IEC 60601-1-8).
- Document usability.
- Technical description.
- Instruction for use.
- Package markings.
- Hospital Beds Side Rail Design.
- Mattress Performance Testing: BFD BX-11, ASTM 1590, CAL 101, CFR1632, CFR1633.
- Re-Manufacturing, Retrofit Kits
- Agency Management
- Statement of Work description.
- Agency Request for Quote and negotiation
- Invoicing.
- Agency Submittal Documentation.
- Technical File.
- Clinical Data Report and Post Market Clinial Data.
- Risk Assessment.
- Insulation Diagram.
- Test Data.
- Product descriptive Information.
- Manuals.
- Pictures.
- Essential Requirements Checklist.
- Documentation Management.
- Standards
- USA
- ANSI/AAMI ES 60601-1:2005 (USA)
- AIMD 90/385/EEC The active implantable medical devices directive
- IVD 95/C172/02 Vitro diagnostic products
- NFPA 99 Standard for Health Care Facilities
- FDA CFR 21 Parts 800-1299 MEDICAL DEVICES
- FDA CFR 21 SUBCHAPTER H - MEDICAL DEVICES
- FDA CFR 21 Part 880.5510 Non-AC-powered patient lift.
- FDA Guidance - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
- UL1431 Personal Hygiene and Health Care Appliances
- UL1069 Hospital Signaling and Nurse Call Equipment
- UL1047 Isolated Power Systems Equipment
- UL1331 Station Inlets and Outlets
- UL863 Time-Indicating and -Recording Appliances
- UL60950 Information Technology Equipment – Safety
- Fire
- BFD IX-11 MATTRESS FIRE TEST (Boston Fire Department).
- California Technical Bulletin 129, and 16 FLAMMABILITY TEST PROCEDURE FOR MATTRESSES
FOR USE IN PUBLIC BUILDINGS
- CFR 1632 Smolder Resistance of Mattresses and Futons
- CFR 1633 Flame Resistance of Residential Mattresses and Futons
- ASTM E 1590 Fire Testing of Mattresses
- UL1895 Mattress
- NFPA 267, Standard Method of Tests for Five Characteristics of Mattresses and Bedding Assemblies Exposed to Flaming Ignition Source
- Canada
- CAN/CSA-C22.2 No. 60601-1:08 (Health Canada).
- EU
- MDD - The Medical devices Directive 93/42/EEC
- 2007/47/EC Medical Device Directive
- EN 60601-1:2006 (EU)
- DOP – 2006-09-12 (EU)
- DOW – 2009-09-12 (EU)
- International
- IEC513 Safety Medical Electrical Equipment
- IEC 601 series to prove that the device itself does constitute an electrical hazard.
- IEC60601-1 Medical Electrical Equipment
- IEC60601-1-1 Systems (Incorporated into the 3rd Edition)
- IEC60601-1-2 EMC (Incorporated into the 3rd Edition).
- IEC60601-1-3 Radiology
- IEC60601-1-4 Programmable Electrical Medical Systems - PEMS (Incorporated into the 3rd Edition).
- IEC60601-1-6 Usability
- IEC60601-1-8 Alarm Systems
- IEC60601-1-9 Environment
- IEC60601-1-10 Closed loop controllers.
- Draft 60601-1-11 Home health care
- IEC60601-2-38 Hopsital Beds
- IEC60601-2-52 Hopsital Beds
- IEC60417-SN Graphical Symbols
- IEC60529 IP Code
- IEC60664-1 Insulation Coordination
- IEC60825-1 Laser Products
- IEC TR60878 Graphical symbols
- IEC60959-1 Information Technology Equipment
- BS 7177 British Standard Specification for Resistance to Ignition of Mattresses, Divans and Bed Bases.
- MHLW (Japan)
- TGA (Australia)
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