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Mandatory INMETRO

Certification for Syringes,

Needles and Infusion/

Transfusion Equipment

UL Health Sciences industry

Presented May 2012

Certification Required Products

• Sterile hypodermic syringes for single use

• Sterile hypodermic syringes for single use, FOR POWER-DRIVEN

SYRINGE PUMPS

• Sterile single-use syringes, with or without needle, FOR INSULIN

• Sterile hypodermic needles for single use

• Sterile injection needles for single use (DENTISTRY)

• Infusion equipment for medical use (infusion sets for single use, GRAVITY

FEED)

• Infusion equipment for medical use (infusion equipment for use with

PRESSURE INFUSION APPARATUS)

• Transfusion equipment for medical use (transfusion sets for single use)

Applicable legislation (all published on 29-DEC-2011):

- Ordinance INMETRO # 501: needles

- Ordinance INMETRO # 502: infusion and transfusion equipment

- Ordinance INMETRO # 503: syringes

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When is Certification Required?

1. To apply for new registration with ANVISA.

2. To revalidate current registrations.

3. To renew current registrations.

4. TO OBTAIN IMPORTATION CLEARANCE! Even products with valid

registrations are required to be certified to obtain clearance from customs.

Otherwise, products will be retained by customs at the port of entry.

5. DEADLINE: JUN-2013

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Certification Process: Procedure

Two certification models are allowed: batch OR type testing with QMS

audit.

• Batch (ISO model 7): Samples are collected at the port of entry. Products

will be retained by customs until testing is completed.

• Type testing + QMS evaluation (ISO model 5): See table below:

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# STEP WHERE? WHO DOES? STANDARD / CRITERIA

1 ISO audit

(14 clauses from ISO 13485) Manufacturing site Closest UL Office

Details in the next slides

2 Collecting samples Manufacturing site

OR distribution center Closest UL Office

3 Laboratory tests Any country Any 3rd party ILAC

accredited laboratory

4 Analysis of test reports Any country Any UL qualified office

5 Issue of the certificate Brazil Engineering team

(UL Brazil)

6 Annual Maintenance ISO audit + laboratory tests. Samples are collected from the manufacturing site (or distribution center) and market in an alternating fashion.

Certification Process: ISO Audit

The closet UL inspection center will verify the following clauses:

- 4.2.3: Control of documents.

- 4.2.4: Control of records.

- 7.2.3: Customer communication.

- 7.4.1: Purchasing Process.

- 7.4.3: Verification of purchased product

- 7.5.1: Control of production and service provision.

- 7.5.3: Identification and traceability.

- 7.5.5: Preservation of product.

- 7.6: Control of monitoring and measuring devices.

- 8.2.1: Customer Satisfaction.

- 8.2.4: Monitoring and measurement of product.

- 8.3: Control of nonconforming product.

- 8.5.2: Corrective action.

- 8.5.3: Preventive action.

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Certification Process: Samples

• Must be collected by the certification company

• Can be collected at the manufacturing site OR at the distribution center

• Sample size is defined by the respective INMETRO ordinance as follows:

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Product # Batches Units TOTAL # Batches Units TOTAL

Sterile hypodermic syringes for single use 3 256 768 3 160 480

Sterile hypodermic syringes for single use for use with POWER-DRIVEN SYRINGE PUMPS 3 256 768 3 160 480

Sterile single-use syringes, with or without needle, FOR INSULIN 3 672 2016 3 420 1260

Sterile hypodermic needles for single use 3 1632 4896 3 1020 3060

Sterile injection needles for single use (DENTISTRY) 3 832 2496 3 520 1560

Infusion equipment for medical use (infusion sets for single use, GRAVITY FEED) 3 225 675 3 150 450

Infusion equipment for medical use (infusion equipment for use with PRESSURE INFUSION

APPARATUS)3

225 675 3 150 450

Transfusion equipment for medical use (transfusion sets for single use) 3 210 630 3 140 420

Initial Certification Annual Maintenance

• UL will collect 3 batches of samples. The second batch is sent for testing if the first one fails. The third

batch is sent for testing if the first fails but the second is approved.

• There is a zero error rejection criteria! If one sample fails, the entire batch is considered non-compliant.

Certification Process: Testing Standards for

Syringes

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Standards Clauses

Sterile hypodermic syringes for single use

NBR ISO 7886-1 5 - 14

Sterile hypodermic syringes for single use, FOR POWER-DRIVEN

SYRINGE PUMPS

NBR ISO 7886-2 5-14, 14.3-14.5

Sterile single-use syringes, with or without needle, FOR INSULIN

NBR ISO 8537 5-12, 14

Certification Process: Testing Standards for

Needles

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Standards Clauses

Sterile hypodermic needles for single use

NBR ISO 7864 4-9, 11-13

NBR ISO 594-1 3, 4.1-4.5

Sterile injection needles for single use - Dentistry

ISO 7885 4.1-4.3, 5, 5.2, 5.4, 6, 6.3

Certification Process: Testing Standards for

Infusion / Transfusion Equipment

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Standards Clause

Infusion equipment for medical use – Infusion sets for single use gravity feed

NBR ISO 8536-4 6.1-6.9, 6.11-1.13, 7.1-7.3

ISO 8536-5 6.2-6.4

Infusion equipment for medical use – Infusion equipment for use with

pressure infusion apparatus

ISO 8536-8 6.1-6.6, 6.8-6.9, 6.11-6.14, 7

ISO 8536-5 6.14, 6.2-6.4

Transfusion equipment for medical use – Transfusion sets for single use

ISO 1136-4 5.1-5.5, 5.7-5.8, 5.11-5.12, 6.1-6.3

ISO 8536-5 6.2-6.4

Certification Process: UL File Construction –

Issue of the Certificate - Marks

• After completion of the ISO audit and laboratory tests, the UL engineer will

be able to finalize the construction of the UL file and issue the certificate.

The certificate is valid for 5 years and is subject to annual maintenance. The

certificate is then published on both UL’s on-line directory and INMETRO’s

website.

• Usage of the certification marks is mandatory on the primary packaging of

the device (see below; minimum sizes; other colours also allowed). OCP

stands for “Product Certification Organization”. UL provides the UL mark

graphic files to its customers.

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50 mm 20 mm 11 mm

Certification Process: Maintenance

Certification maintenance consists of an annual ISO audit and

laboratory tests. The procedure for the audit and tests is the same as

those performed in the initial certification, except for 2 major

differences:

• Reduced number of samples for testing (please see slide 8)

• Samples are collected from the manufacturing site (or distribution center)

and market in an alternating fashion.

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FAQ

1. Is ISO 13485 certification mandatory? No, it’s not necessary, but the initial

audit carried out by UL is based on this standard.

2. Are tests performed by the manufacturer at its own facilities valid? Only

tests performed by 3rd party ILAC accredited laboratories are accepted.

3. Who performs the ISO audit? Any UL office with qualified ISO staff can

carry out the audit on behalf of UL Brazil.

4. How long does the ISO audit take? It takes one day for ISO verification

ONLY. If samples need to be collected, then additional days might be

required depending on the number of families of devices.

5. What is the criteria to divide products into families and who determines the

criteria? The criteria to group the different versions of the product into

families is determined by the respective INMETRO ordinance. UL

partners with the manufacturer to define the families.

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Incorporate Integrated Assessments to Access

Global Markets with UL

THANK YOU.

• For more information on UL Health Sciences services visit:

http://ul.com/medical

• For more information on UL visit:

http://www.ul.com/global/eng/pages/corporate/aboutul/

• To see available UL marks visit:

http://ul.com/global/eng/pages/corporate/aboutul/ulmarks/mark/

• To locate your local UL contact visit:

http://www.ul.com/global/eng/pages/corporate/contactus/

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