Regulatory Compliance

Policy

ADVAN Int’l Corp는 저희 의료용 디스플레이 제품이 유통되는 각 국가의 규제기준 및 승인을 준수하기 위해 최선을 다하고 있습니다.
저희 디스플레이들은 의료품질시스템의 관리하에 제품 안전과 전자기파호환 기준을 충족하도록 설계 및 테스트하고 있습니다.

Quality Management System

ADVAN INT’L CORP.

ISO 13485: 2003

Regulatory1

Scope: Manufacturing, testing, distribution, and servicing of display monitors for medical imaging and health care monitoring systems for OEM customers.

Regulatory2

 

Notified Body: BSI

 

ADVAN INT’L CORP. KOREA BRANCH

ISO 13485 : 2003

certificate

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

Regulatory4

 

 

Notified Body: UL DQS Inc.

 

Declaration of Conformity

ADVAN 의료용 컬러 디스플레이

사용목적: 스크린 상에 정보, 그래픽 데이터, 이미지와 비디오를 표시 (비멸균 장치)

GMDN code: 36612 (Monitor, VDU, colour)

ADVAN 의료용 컬러 디스플레이는, 그 사용목적에 근거하여, 의료기기지침의 분류(Article 1 of the Medical Device Directive (MDD) 93/42/EEC and based on Rule 12; Annex IX)에 따라 유럽연합(EU)에서 의료기기로 판매됩니다.

 

 

Product Safety

Regulatory5

 

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

 

Regulatory6

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

 

Regulatory9

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)

Regulatory8

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

Regulatory6

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

Regulatory7

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

Regulatory9

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 Corp는 EU RoHS와 REACH 환경 규제를 준수하기 위해, 전문지식과 고객 및 공급업체와의 긴밀한 협력 관계를 기반으로 노력하고 있습니다.

 

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.