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Step 1

Step 1

Internal Auditing to check and review your Medical Electrical Equipment.

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Step 2

Step 2

Determining and designing documents as per guidelines of the appropriate Standards.

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Step 3

Step 3

Filing of application and obtaining the IEC 60601 Certification.

Overview of IEC 60601 Certification

IEC 60601 is a widely accepted series of International Standards that applies to basic safety and essential performance of all medical electrical equipment and medical electrical systems for their use in the home healthcare environment. It applies regardless of the intention of use of such medical electrical equipment and medical electrical systems by a lay operator or by trained healthcare personnel. Home healthcare includes the following:

  • Dwelling place in which patient lives
  • Places where patients are present both indoors as well outdoors, except the professional healthcare facility environments where operators with medical training are continually available when patients are present.

IEC 60601 is a recognised series of technical standards which ensures that a single electrical, mechanical, thermal or functional failure poses an unacceptable risk to the patient or the operator. It is considered to be a prerequisite for the commercialisation of medical electrical equipment.

This IEC 60601 does not apply to the followings:

  • In Vitro Diagnostic Equipment does not fall within the definition of Medical Electrical Equipment which is covered by the IEC 61010 series.
  • Implantable parts of active implantable medical device covered under the ISO 14708 series.
  • Medical gas pipeline systems are covered by ISO 7396-1.
  • Medical equipment must complete the compliance evaluation, testing and device approval before being available in the market.

Benefits of IEC 60601 Certification

Following are the benefits of obtaining IEC 60601 Certification:

  • Customer's confidence
  • Minimal risk
  • Global support
  • International recognition
  • Risk management
  • Manufacture of safe medical electrical equipment

Requirements included in IEC 60601 for IEC 60601 Certification

Following are the requirements included in IEC 60601 for obtaining Certification under the same:

  • Risk Management: ISO 14971 risk management standard must be applied.
  • Essential Performance: Manufacturers have to establish specific performance characteristics under abnormal or faulty conditions. It is also a test criterion in assessing if a hazard is present after a specific test, and manufacturers must declare specific essential performance criteria in the product's technical description.
  • Humidity: Humidity testing is required under the IEC 60601.
  • Documentation: A number of documents are required for user manuals and instructions for use (IFU). Also, the electronic version of all accompanying documentation must apply usability engineering process as covered in collateral standard, IEC 60601-1-6, usability in determining the information that must be presented.
  • Marking and Labelling: equipment labelling must have a unique serial number or lot batch identifier, date of manufacture or expiry (use-by) date and manufacturer's contact number.
  • Electrical Hazard: The protection from potential electrical hazards includes defibrillation protection, protective earth and creepage and clearance distances. There are limits for leakage current testing for the functional earth connections. Protective earth testing with a power supply cord is needed for the devices equipped with the appliance inlets. If reconnection presents a potential hazard to a user, permanent equipment must include a power lockout device.
  • Mechanical Hazards: testing for any mechanical hazard related to the instability and mobile equipment must be notified to include functional testing.
  • Temperature Testing: there is a temperature limit defined under IEC 60601. For overflow, equipment is designed to ensure that basic safety and essential performance are maintained all time.
  • Programmable Electrical Medical Systems (PEMS): IEC has incorporated many specific requirements and medical device software life cycle processes applicable to the equipment & systems whose operation depends on software or any programmable element. It has also incorporated validation requirements for the equipment connected to a network.
  • Construction: for mechanical strength, basic safety & essential performance are included instead of unacceptable risk.

Other requirements under IEC 60601 Standard are as follows:

  • Type B (body) equipment operates within the home healthcare vicinity but without patient contacts, such as x-ray machines, hospital beds, LED operating lighting & MRI scanners.
  • Type BF (body floating) equipment that makes physical contact with the patients, such as blood pressure monitors, ultrasound equipment and thermometers.
  • Type CF (cardiac floating) equipment that makes physical contact with the heart, such as defibrillators and dialysis machines.
  • Means of Operator Protection (MOOP)
  • Means of Patient Protection (MOPP)
  • Professional healthcare facilities with attending medical staff such as hospitals, intensive care units and dental offices.
  • Home healthcare
  • The special environment includes somewhere with high levels of electromagnetic disturbance or where particular high-power medical equipment is used.

Documents Required for IEC 60601 Certification

The document under IEC 60601 is not mentioned, and for IEC 60601 Certification, documents similar to ISO 14971 Certification are required only. And the following are the documents required for ISO 14971 Certification:

  1. Risk management plan
  • Scope of risk management planned activities for the life cycle of the product.
  • Assignment of risk management responsibilities
  • Assignment of the role of management
  • Requirements for review of the risk management activities
  • Criteria of the risk acceptability, based on the manufacturer's policy for determining acceptable risk, and criteria for accepting risk when the probability of any harm is not possibly estimated
  • A methodology to evaluate the residual risk
  • Verification activities of implementation as well as the effectiveness of risk control measures.
  • All activities relating to the collection and review of relevant products, including the post-production information
  1. Risk management file
  • Analysis of risk
  • Evaluation of risk
  • Implementation and verification of all risk control measures
  • Results of evaluation of the residual risks
  1. Import details, in case of import
  2. Information for the user of those accountable for the installation, use, maintenance, decommissioning and disposal of medical device
  3. Information related to safe use
  4. Instruction for use
  5. Technical description
  6. Installation manual
  7. Quick reference guide
  8. Documents stating results achieved or providing evidence of all the activities performed, such as records.

Under ISO 14971, Documents required for Quality Management System are also included, such as the following:

  • Roles of the organisation undertaking the applicable regulatory requirements
  • Quality Manual
  • Medical device file
  • Records of validation of computer software's application
  • Document control procedure
  • Record control procedure
  • Quality policy
  • Quality objectives
  • Responsibilities and authorities
  • Management review procedure and records
  • Procedure for training
  • Infrastructure and maintenance activities requirements
  • Arrangements for control of contaminated or potentially contaminated product
  • Product realisation planning outputs
  • Work environment requirement
  • Records of customer requirements review results and actions arising from it.
  • Arrangements for communication with customers
  • Design and development procedure
  • Risk management in the product realisation process
  • Design and development planning
  • Design and development outputs
  • Records of design and development review
  • Design verification plans, conclusions and results
  • Design validation plans, conclusions and results
  • Transfer of design and development outputs to the manufacturing process
  • Control of design and development changes process and records
  • Design and development file
  • Purchasing procedure
  • Evaluation and selection of suppliers' criteria and records
  • Verification of purchased product record
  • Medical device or batch that provides traceability record
  • Cleanliness of the product requirements
  • Medical device installation and verification of installation requirements
  • Records and processes for serving the medical device
  • Sterilisation procedure records
  • Records and process of production and service provision process validation
  • Records and process for validation of a process for sterilisation and sterile barriers systems
  • Product identification procedure
  • Traceability procedure
  • Records of traceability, including name and address of shipping package consignee
  • Report on changes in customer property
  • Conformity of product preserving procedure
  • Monitoring and measuring procedure
  • Calibration records
  • Validation of application of computer software used for monitoring and measuring procedures and records
  • Customer feedback procedure
  • Complaint handling procedure and records
  • Reporting to regulatory authorities' records
  • Internal audit procedure
  • Audits and their results records
  • Identity of the person authorising the release of the product
  • Control of non-conforming product procedures and record
  • Rework record
  • Data analysis procedure and records
  • Corrective action procedure and records
  • Preventive action procedure and records

The information and documents that are additionally required under IEC 60601 are as follows:

  1. Medical Standard List with their publication dates
  • Harmonised standards with publishing dates, collateral and particulars
  • Anticipated publish dates for all new standards, editions and amendments
  1. Evaluation Package
  • Summary of IEC 60601 standard
  • Applicable requirements
  • Guidance information and interpretations
  • To help in the evaluation of medical electrical equipment to the requirements of the standard. To help people understand and meet requirements for medical devices.
  • Purchased copy
  1. Risk Management Guidance Form for ISO 14971
  2. Risk Management Guidance Form for IEC 60601-1
  3. Label Manual Checklist
  • Identification, Marking and Documents
  • Marking on outside of Medical Electrical Equipment or its parts
  • Marking on inside of Medical Electrical Equipment or its parts
  • Marking on Controls and instruments
  • Safety signs
  • Symbols
  • Indicator lights and controls
  • Accompanying documents
  • Technical description separable from instructions for use (IFU)
  • Additional accompanying documents and marking requirements throughout IEC 60601
  • Details of temperature
  1. Medical Alarm Standards Cross Reference
  2. Medical Standard Project Scope Tool
  3. Critical Components Guidance Documents
  4. National Differences Evaluation Package

The procedure required for obtaining IEC 60601 Certification

There are four essential steps to be followed while obtaining the IEC 60601 Certification:

Optional Preliminary Audit

A voluntary Site inspection is conducted, and all the required documents are reviewed, assessing the organisation's readiness for scale I and II Auditing Phase.

Audit: Stage I

Assessment of the eligibility for IEC Certification is understood as well as determined by results of the on-site Auditing, business assessment and risk management documents analysis.

Audit: Stage II

On-site evaluation of the Medical Electrical Equipment and Medical Electrical System as well as Risk Management for excellence in areas where practice and efficiency are applied.

Certification

An official confirmation certifies IEC standards for Medical Electrical Equipment and Medical Electrical Systems, integrity and compliance and thus the grant of IEC 60601 Certification.

Frequently Asked Questions

The International Electronical Committee (IEC) governs medical equipment design and determines the safety standards that directly relate to the handling, connection to or use of the medical equipment. IEC 60601 standards consist of two parts, IEC 60601-1 and IEC 60601-2, and each part builds a number of basic or collateral standards. IEC 60601-1 3rd edition is a series of technical standards for Medical Electrical Equipment & are used as a basis to test their safety and effectiveness.

ISO 14971 is the risk management standard for all medical devices, including software as a medical device and in vitro diagnostic medical devices. It is a structured framework for manufacturers within which experience, insight and judgement are applied systematically to manage the risks associated with the use of medical devices. The purpose of ISO 14971 is to help medical device manufacturers establish risk management that such manufacturers can use, and such purposes include the followings:
  • Identify the hazard
  • Estimate and Evaluate risks
  • Develop, implement and monitor the Risk effectiveness
  • Control Measures.

EN 60601 is a group of standards that cover the safety, essential performance and electromagnetic compatibility of the Medical Electrical Equipment and the related systems. It is similar to the international standard IEC 60601, and it comprises more than 70 individual standards.

The basic devices that are included under the meaning of Medical Electrical Equipment are as follows:
  • Cardiac defibrillators
  • High-frequency surgical equipment
  • Infant incubators and warmers
  • Medical lasers
  • Patient monitors
  • Patient ventilators
  • Ultrasound equipment, including diagnostic and therapeutic

The 3rd Edition of IEC 60601 extends the focus on patients to require an overall means of protection, commonly known as MOP, that combines one or more means of operator protection (MOOP) and means of patient protection (MOOP). So, it guards against any failure and recognises that the potential hazards observed by every user can be different.

The functions that the IEC 60601 Series establish are as follows:
  • Represents global consensus for compliance
  • Provide a reference for minimum safety requirements of Medical Electrical devices
  • Outline design and performance requirements
  • Establish regulatory requirements for the market approval

The environment intended to use under IEC 60601 is defined under its 4th edition, which includes the following:
  • Professional healthcare facilities, for example, hospitals, clinics and other medical facilities
  • Home healthcare settings
  • Special environments, like industrial zones and military installations.

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