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ISO 10993-1:2018 Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices | ISO 10993-1:2018

The ISO 10993-1: 2018 is the standard for biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. It also includes:

  • General biocompatibility testing considerations, including test article preparation
  • Specific considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments
  • Chemical assessment recommendations 8 and considerations for labeling devices
  • Device Master Files (MAFs) for Biocompatibility Evaluations, which includes information that goes in MAF

This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system to assess biological evaluation of primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medical device, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.

A certificate to ISO 10993-1 must include Risk Management. The risk assessment should also consider the proposed clinical use of the device, including the anatomical location, duration of exposure, and intended use population. For example, for pediatric patients with a limited life expectancy, the tolerance for risk associated with a permanently implanted medical device may be higher than the tolerance for risk from the same device in an otherwise healthy pediatric population. The potential exposure duration should also consider which material components of the device have direct or indirect contact with tissue, and whether exposure would be a one-time exposure, a constant exposure over time, or an intermittent exposure over time that could have a cumulative effect

Biological evaluation of medical devices is performed to determine the acceptability of any potential adverse biological response resulting from contact of the component materials of the device with the body. The device materials should not, either directly (e.g., via surface-bound chemicals or physical properties) or through the release of their material constituents:

  1. produce adverse local or systemic effects;
  2. be carcinogenic; or
  3. produce adverse reproductive and/or developmental effects, unless it can be determined that the benefits of the use of that material outweigh the risks associated with an adverse biological response.

Therefore, evaluation of any new device intended for human use requires information from a systematic analysis to ensure that the benefits provided by the device in its final finished form will outweigh any potential risks produced by device materials over the intended duration and use of the device in or on the exposed tissues.

Any facility desirous of having a globally acceptable quality assurance system for biological evaluation of medical devices needs to get certified to ISO 10993-1:2018.

Any facility desirous of assuring customers about their quality systems for biological evaluation of medical devices should get ISO 10993-1 certification.

Any facility desirous of having interests of all stake holders covered in their system and has adequate provisions for mitigating risks in their processes must get ISO 10993-1 Certification, confirming safe and risk free manufacture of medical devices

Any facility desirous of having a strong marketing tool to showcase their quality capabilities in limiting biological infestation on medical devices must get ISO 10993-1 certification

Any facility desirous of having a complete system which covers all aspects of operations in one single system for management review and continual improvement in eliminating biological infestation on medical devices must have ISO 10993-1 certification

  • Process of ISO certification starts with preparation of a Quality Management System (QMS) for Biological Evaluation of medical devices
  • ISO Consultants assist in developing a comprehensive, QMS to meet all requirements of ISO 10993-1 and Third-Party Certification Body stage 1 audit requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all ISO 10993-1 requirements or not
  • An ISO 10993-1 consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits or provides ISO Internal Auditing Services to audit all processes, all ISO 10993-1 Standard requirements and effective implementation of ISO 10993-1 Standard
  • Facilities need to initiate corrective actions and continual improvement is realized through control of nonconforming products/services.
  • Facilities need to implement the prepared QMS for a minimum of 3 months and gather adequate data and record to show as evidence
  • Managements of the facilities need to conduct one full scale review of the entire QMS and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO requirement not being fulfilled
  • Once a QMS is ready, Internal audit is performed and one full set of Management review takes place, the facility needs to contact a certification Body for certification audit
  • Certification Bodies conduct Audit in 2 stages. During Stage 1, ISO audit will evaluate the documentation system and basic requirements of meeting ISO Requirements
  • Certification Body will return for final audit where all ISO 10993-1 Requirements will be thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance
  • Once certification Body is satisfied, recommendation is sent to accrediting agencies to issue ISO certification
  • QSE Consultants can prepare your facilities to have a Quality Management System (QMS) and associated documents/records to show as evidence of having implemented the system in complete requirements for primary packaging of medicinal products.
  • QSE consultants ensure that each facility needs to prepare documentation to show as evidence of having streamlined processes that ensure Quality in manufacture and supply of medical devices which have no biological infestation
  • Example is the documentation required to show the evidence on cleaning and sterilization preserved on medical devices
  • QSE ensures use of microbial free facilities for manufacture and supply of medical devices
  • QSE provides differentiation in documentation between medical devices with human or animal contact versus those which do not have contact
  • It is acceptable that no facility/company likes to produce a bad quality product or service but without an established quality management system it is difficult to prevent quality wastages and contribute to hygiene of end user
  • It is therefore necessary to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality for medical devices
  • All facilities engaged in production of products or offering services will need a Quality Management System QMS for primary packaging of medicinal products
  • ISO Consulting services are required to assist organizations to build a QMS that can prepare organizations with a robust system to produce quality products and services
  • ISO Consultants assist in meeting “Annex SL. A section of the ISO/IEC directives part 1that prescribes how ISO Management System Standard (MSS)should be written which in turn is in line with ISO requirements
  • ISO 10993-1 is an international standard dedicated to build QMS for primary Biological evaluation of medical devices and pave way for continual improvement in any facility
  • QSE consultants can provide detailed explanation on the intent of the standard and build a Quality management system
  • IQSE Consultants assist in developing a comprehensive simplified QMS to meet all requirements of ISO 10993-1 and Third-Party Certification Body stage 1 audit requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all the requirements of ISO 10993-1 or not
  • QSE provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits or provides ISO Internal Auditing Services to audit all processes, all ISO10993-1 Standard requirements and effective implementation of ISO10993-1 Standard
  • Internal Quality Audits conducted by QSE consultants, help the facilities to find all deficiencies in their implementation which are not normally found during organizations first party audits
  • QSE consultants assist organizations to effectively control documented information (Documents and Records) related to changes, conducting management review meetings covering all management review inputs (as per ISO10993-1 requirements)

Including the trends to be monitored, internal audit results are fully addressed, risk related activities identified/assessed/mitigated, root-cause analysis is fully applied, corrective actions are initiated and continual improvement is realized

  • There will be an annual surveillance audit to ensure implementation of certified QMS for medical devices
  • Consulting firms provide distinction in documentation between implanted medical devices with no human or animal contact.
  • The certification is renewable every three years
  • QSE has over 27 Years of standing in the field of Consulting, Auditing and Training for any ISO Standard, Medical Devices Standards, Sector Specific Standard, AISC standard or Food Safety Standard
  • QSE has helped over 700 facilities to earn their ISO certifications and other certifications. All QSE customers pass final audits with no or minimal nonconformities
  • Over 98 % of QSE customers passed ISO certification audits with nil nonconformities first time around
  • Our Success rate for certification is 100%
  • Unlike our competitors QSE a unique, comprehensive, evidence based simplified single level system which is easy to implement and provide evidence for implementation to earn ISO certification
  • Templated designed by QSE are tried and tested. They are perfect. Facilities using the documentation developed by QSE do not have to struggle for evidence
  • Evidence is built into the system. The facility needs to only follow the given formats, and tables to sail through a certification audit without nonconformity or with minimal nonconformities
  • QSE engages all competent auditors to conduct internal audits or suppler audits.
  • President QSE, Baskar Kotte is an original and active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed ISO 14000 family of standards, ISO/US TAG/ TC 301 (TC 242) which developed ISO 50001 and   ISO 19011 the Guiding standards for Auditing. Mr. Kotte also participated and provided input to the development of the current ISO 10993-1:2015,
    ISO 140001:2015, ISO 50001:2018 family of Standards and ISO 19011:2018 revised
  • Several of our competitors engage in audits through Audit checklists. QSE does not perform audits by Audit checklist, which is not an evidence gathering ISO audit. QSE performs ISO quality audits by thorough audit covering all requirements of ISO standards clause by clause

The benefits of implementing ISO 10993-1 management systems are diverse and will be seen in all departments of your company. 

The benefits of certification:

  • ISO 10993-1 Certification Helps organizations in the medical devices sector to minimize or eliminate instances of contamination, mix-ups, and errors
  • ISO 10993-1 certification is a mandatory requirement for facilities manufacturing medical devices
  • ISO 10993-1:2018 Standard aligns with ISO 9001:2015 and easily integrates both the standards
  • ISO 10993-1:2018 is a great marketing tool to get international market share of packaging of medicinal products for medical devices
  • Certified companies with ISO 10993-1:2018 certification will have very few or no audits from FDA
  • ISO 10993-1 certification helps facilities avoid recall of packaging for medicinal products
  • ISO 10993-1:2018 certification avoids or minimizes FDA audits.
  • ISO 10993-1 is an Effective Risk Management tool
  • ISO 10993-1:2018 certification enhances customer satisfaction through Problem Solving and Continual Improvement
  • Aligns organization’s Strategic Direction with Customer Focused Objectives and Goals, Quality Policy, and all Key Performance Indicators (KPIs)
  • Promotes Risk-Based Thinking, Process Approach, and Continual Improvement
  • Through ISO Internal Auditing provides effective management tool to run any business considering from “Quote to Cash” processes for enhancing customer satisfaction and Bottom-Line Improvement

QSE has assisted over 700 organization in obtaining ISO and other certifications, contact details can be furnished on demand for any certification.

  • First-Party Audit: Audits performed by a team within the facility is called First-Party Audit. This audit could be delegated to Consulting companies like QSE for thoroughness
  • Second-Party Audit: Audits performed by organizations on their suppliers is called Second-Party Audit
  • Third-Party Audit: Audits performed by Certification Bodies is known as Third-Party audit

Third-Party audit Certification Bodies (accredited by International Accreditation Forum or IAF) perform the audits on the organizations to grant ISO 10993-1. Certifications with demonstrated evidence of conformity to all the requirements of ISO 10993-1.

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body of human or animal.

Cost for certification always depends on the number of processes within the facility number of people employed and the number of people needing training, number of processes involved etc. Cost is always considered in view of several tangible and intangible benefits accruing from certification.

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