Regulatory Compliance

Policy

Advan Int’l Corp. is committed to be in compliance with regulatory standards and approvals in each country that our medical displays are distributed. Our displays are designed and tested to meet product safety and electromagnetic compatibility standards under medical quality management systems.

Quality Management System

ADVAN INT’L CORP.

ISO 13485: 2003

 

Scope: The design and manufacturer of medical image display monitors.

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Notified Body: BSI

 

ADVAN INT’L CORP. KOREA BRANCH

ISO 13485 : 2003

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Scope: The design and manufacturer of medical image display monitors and signal converters.

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Notified Body: UL DQS Inc.

 

Declaration of Conformity

ADVAN Medical Color Displays

Intended use: equipment that displays information, graphic data, image and video on its screen (non-sterile device)

GMDN code: 36612 (Monitor, VDU, colour)

ADVAN Medical Color Displays based on its Indications for Use is intended to be marketed as a Medical Device in the European Union as defined in Article 1 of the Medical Device Directive (MDD) 93/42/EEC and based on Rule 12; Annex IX, Classification Criteria, is considered to be a Class I device.

 

Product Safety

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UL 60601-1 medical electrical equipment requirements standard for safety for U.S.
CAN/CSA-C22.2 No. 601.1-M90 medical electrical equipment requirements standard for safety for Canada

 

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EN 60601-1 Medical electrical equipment requirements standard for safety and essential performance for EU (European Union countries)

 

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GB 4943.1 Safety standards for Information Technology Equipment (ITE) for China

 

AS/NZS 3200-1-0 medical electrical equipment requirements standard for safety for Australia and New Zealand

 

IPX1, IPX2, IPX3, IP23

IP Code is the International Protection Marking that classifies and rates the degree of protection against the intrusion (including body parts such as hands and fingers) of dust and water by mechanical casings and electrical enclosures.

The first digit indicates the level of protection that the enclosure provides against the ingress of solid foreign objects

Code Level for solid particle

Object size protected against

Effective against

IP0X - No protection against contact and ingress of objects
IP1X >50 mm Any large surface of the body, such as the back of a hand, but no protection against deliberate contact with a body part
IP2X >12.5 mm Fingers or similar objects

 

The second digit indicates the level of protection that the enclosure provides against harmful ingress of water

Level

Protected against

Testing for

Details

IPX0 Not protected - -
IPX1 Dripping water Dripping water (vertically falling drops) shall have no harmful effect.

Test duration: 10 minutes

Water equivalent to 1 mm rainfall per minute

IPX2 Dripping water when tilted up to 15° Vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15° from its normal position.

Test duration: 10 minutes

Water equivalent to 3 mm rainfall per minute

IPX3 Spraying water Water falling as a spray at any angle up to 60° from the vertical shall have no harmful effect.

Test duration: 5 minutes

Water volume: 0.7 litres per minute

Pressure: 80–100 kPa

 

Electromagnetic Compatibility (EMC)

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Part 15 Class B U.S. Code of Federal Regulations, Title 47, Part 15 (47 CFR 15) is an oft-quoted part of Federal Communications Commission (FCC) rules and regulations regarding unlicensed transmissions. Subpart B deals with unintentional radiators—devices for which the purpose is not to produce radio waves

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EN 60601-1-2 Medical electrical equipment requirements standard for EMC for EU (European Union countries)

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VCCI, Class B The Voluntary Control Council for Interference by Information Technology Equipment (VCCI), EMC standards for Japan.

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GB 9254 EMI standards for Information Technology Equipment (ITE) for China
GB 17625.1 EMS standards for Information Technology Equipment (ITE) for China

 

AS/NZS 3200-1-2 medical electrical equipment requirements standard for EMC for Australia and New Zealand

 

Environment

Advan Int’l Corp is applying its own efforts and expertise and relying on close partnerships with customers and suppliers to achieve EU RoHS and REACH compliance.

RoHS: complying RoHS threshold level in accordance with Directive 2002/95/EC

REACH: complying REACH criteria for SVHC for article(s) in accordance with Directive 67/548/EEC

 

Conflict Minerals

ADVAN Int’l Corp continuously defines and manages our supply chain to reduce the risk of using “conflict minerals” – tin, tantalum, tungsten and gold (3TG) is not used in our products are contributing to the ongoing conflict in the DRC and adjoining countries*.

Conflict Minerals Reporting & Declaration: by the Electronic Industry Citizenship Coalition (EICC) and the Global e-Sustainability Initiative (GeSI) Conflict Minerals Reporting Template

* Adjoining countries includes countries that share an internationally recognized border with the Democratic Republic of the Congo. There are nine of these countries: Angola, Burundi, Central Africa Republic, Republic of the Congo, Rwanda, South Sudan, Tanzania, Uganda, Zambia.