Standards

Our Compliance Standards and Regulations

At Pacific Corp, compliance is at the core of our operations. We strictly adhere to international, national, and industry-specific standards to ensure the safety, efficacy, and quality of our products and services. Below is a comprehensive list of the standards and regulations we comply with:

International Standards

ISO 13485: Quality management system for the design and manufacture of medical devices.

ISO 9001: Standards for quality management systems and processes.

ISO 14001: Environmental management systems to ensure eco-friendly operations.

IEC 60601: International standards for the safety and performance of medical electrical equipment.

North American Regulations

Health Canada (Canada Health Standards):

Adherence to the Medical Device Regulations (SOR/98-282).

Compliance with Canadian Environmental Protection Act for waste and materials.

Conformance with Canadian Building Code for hospital infrastructure.

FDA (U.S. Food and Drug Administration):

Compliance with FDA Title 21 CFR Part 820 for quality systems.

Registration and listing under the FDA’s medical device regulations.

Adherence to cGMP (current Good Manufacturing Practices).

ASHRAE Standards:

Compliance with ASHRAE 170: Ventilation for Healthcare Facilities.

Standards for HVAC and refrigeration in healthcare facilities.

European Union Standards

CE Marking: Certification for products meeting EU safety, health, and environmental protection standards.

MDR (Medical Device Regulation 2017/745): Ensures conformity of medical devices sold within the EU.

EN 60601: Standards for electrical safety in medical devices.

WEEE Directive: Compliance with Waste Electrical and Electronic Equipment disposal regulations.

Other Key Regulations

NFPA 99: Health Care Facilities Code for electrical systems and gas distribution.

WHO (World Health Organization) Guidelines: Compliance with global health and safety recommendations.

GMP (Good Manufacturing Practices): Standards for production processes to ensure high-quality output.

HIPAA Compliance (Health Insurance Portability and Accountability Act): Ensures the confidentiality and security of healthcare data in applicable scenarios.

By adhering to these standards, we ensure that our products and solutions are safe, reliable, and trusted by healthcare providers around the globe.