medical certification area

system authentication

Brief introduction of biocompatibility (ISO10993)

In 1992, ISO 10993-1:1992 Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing was promulgated by the International Organization for Standardization. Currently, the FDA reviews 510 (k) and PMAs are based on "Blue book memory and um G95-1, Use of International Standard ISO 10993, Biological evaluation of medical device part 1: Evaluation and testing".

Consider the chemical properties of medical equipment materials, the nature, degree, frequency and time of contact with human body.

Many medical devices have long-term experience in using physical or chemical materials to verify their safety, and do not necessarily perform all tests required by FDA guidelines. The manufacturer needs only to complete substantive equivalence comparisons, but FDA inspectors will determine the need for additional tests.

Therefore, most of the biocompatibility tests in the world are based on the ISO 10993 "Biological Assessment of Medical Devices".

ISO 13485 introduction

In July 2003, ISO officially issued the latest edition of ISO 13485:2003, with ISO 9001:2000 as the blueprint, with the characteristics of medical equipment products to add or delete some provisions, become a separate standard.

International standard ISO 14971 integrates the relevant medical equipment standards, including the third edition of IEC 60601-1, IEC 60601-1-6, ISO 13485 and AMI SW-68. It is the only development of medical equipment risk management assessment tool in the world.

In Europe, ISO 14971 has been adopted as the European General Standard for Medical Equipment. The Food and Drug Administration of the United States (FDA) has also approved this standard. Japan has also adopted it as the Japanese industrial standard. It is expected that other countries will gradually incorporate this standard into the standard.

product certification

Brief introduction of sterilization efficacy

1. Common sterilization methods:

Radiation sterilization

Ethylene oxide gas sterilization

Dampness and heat sterilization

Dry heat sterilization

Filtration and removal of bacteria

Two. The stage of sterilization effectiveness:

The sterilization efficacy can be divided into three kinds before sterilization, sterilization and sterilization.

1. before sterilization: Environmental Assessment (dust and drop test) and product evaluation (number of bacteria tested)

2. sterilization: BI indicator & CI discoloration paper test

3. after sterilization: product assessment (aseptic testing) and packaging validation

For ethylene oxide or radiation sterilization, additional tests are required in accordance with their standards (e.g. ISO 11137, ISO 11134..., etc.).

Introduction to Safety & EMC

At present, the common testing of medical electronic products is:

1. SAFETY [IEC 60601-1-1]: Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00).

EMC [IEC 60601-1-2]: Electromagnetic Compatibility-Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed.2.1 (11/04).

In addition, all countries also use this standard as a basis for standard harmonization, for example:

Us: UL 60601-1 Ed.1 (4/25/2003)

Japan: JSA JIS T0601-1 (12/27/1999)

EU: EN 60601-1 (8/1990) + Am.1 (5/1993) + Am.2 (6/1995) + Am.11 (5/1993) + Am.12 (5/1993) + Am.13 (1/1996)

Canada: CSA C22.2 No. 601.1-M90 (11/2003)

Taiwan: CNS 14509.

introduction of medical certification in mainland China

China's State Drug Administration (SFDA), equivalent to the Food and Drug Administration of the United States (FDA), is responsible for the registration and supervision of imported medical equipment.

Registration process:

US medical product certification

In the United States, the Food and Drug Administration (FDA) is the statutory body that inspects and controls food, drugs, cosmetics and medical equipment sold to consumers. FDA's branch unit and radiation health center CDRH) specialize in medical devices. The degree of supervision depends on the type of equipment (category I, II, or III; where the risk of category I is low and that of category III is high)

Category I: Applicable to all medical and conventional equipment registration, quality system requirements (QSR, the original medical equipment report (MDR), good manufacturing standards (GMP) and foreign manufacturers designated U.S. agents or formal agents.

Category II: before entering the market, statement [510 (k)]

Category III: approval before entering the market [PMA]

There are three ways to apply for 510 (k):

1. traditional submission and application of new equipment require performance reports.

2. special submission applies to minor modifications of equipment, such as the result of design control procedures.

3. Simplified submission is made when the manufacturer guarantees and declares that the product meets existing FDA accreditation standards.

overview of European Union Medical Device certification

The European Union divides medical device products into four categories: Category I, type II A, type II B and class III.

Type CE products should be labeled with self declaration.

Type CE products should be labeled with self declaration.

If the products of Class II a, Class II B and Class III are to be labeled with CE, they must be verified by a certification authority designated by the European Union.

The European Union also stipulates that the prerequisite for CE certification of these products is that the manufacturer must be able to pass the ISO13485 quality system certification and obtain the ISO13485 quality system certification certificate, and the certificate issuing unit should be the certification authority approved by the European Union.